Who is the manufacturer of Neocis Guidance System (NGS) with Patient Splints?

Neocis, Inc. filed the 510(k) submission for Neocis Guidance System (NGS) with Patient Splints (K200805).

What is the FDA product code for Neocis Guidance System (NGS) with Patient Splints?

PLV. It is classified under 21 CFR 872.4120 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Neocis Guidance System (NGS) with Patient Splints?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Neocis Guidance System (NGS) with Patient Splints?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Neocis Guidance System (NGS) with Patient Splints

Q: What are the predicate devices for Neocis Guidance System (NGS) with Patient Splints?

X-Guide Surgical Navigation System (K150222).

K200805 · Neocis, Inc. · PLV · Jul 28, 2020 · Dental

Device Facts

Record ID	K200805
Device Name	Neocis Guidance System (NGS) with Patient Splints
Applicant	Neocis, Inc.
Product Code	PLV · Dental
Decision Date	Jul 28, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4120
Device Class	Class 2

Intended Use

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Device Story

NGS is a computerized dental stereotaxic instrument for planning and guiding dental implant surgery. Input: CBCT scan for virtual planning. Operation: Surgeon plans implant placement in software; system uses a Patient Tracker (PT) and Edentulous Patient Splint (EPS) or Chairside Patient Splint (CPS) to track patient movement in real-time. The system provides haptic feedback by constraining a standard powered bone-cutting instrument to the pre-operative plan; it automatically adjusts the cutting angle, position, and depth if the patient moves. Used in dental clinics by surgeons. Output: Physical, visual, and audible guidance during osteotomy. Benefits: Minimally invasive, flapless procedures with high accuracy; improved safety via real-time motion compensation.

Clinical Evidence

Prospective, two-center, non-randomized, non-controlled IDE feasibility study (G190282). Sample: 10 adult patients (male, partially or fully edentulous), 67 total implants. Endpoints: usability, safety, effectiveness. Results: No adverse events or usability concerns reported. Implant location accuracy (pre-op plan vs. post-op CT) met system specifications. Bench testing included EPS deflection, kinematic mount repeatability, and total system accuracy on typodonts.

Technological Characteristics

Materials: Ixef HC-1022, stainless steel, titanium alloy. Sensing: Force/Torque (F/T) sensors (+/- 30 N, +/- 2 Nm). Connectivity: Networked/standalone. Sterilization: Steam (ISO 17665-1). Software: Moderate level of concern. Accuracy: RMS < 1 mm (lateral/depth), RMS < 6.0° (angular). Power: 120VAC/60Hz. Class I equipment.

Indications for Use

Indicated for partially edentulous and fully edentulous adult patients requiring dental implants. Contraindicated for patients with insufficient bone quality to retain the Edentulous Patient Splint (EPS) or history of jaw/TMJ pain.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

X-Guide Surgical Navigation System (K150222)

Reference Devices

Neocis Chairside Splint (K173402)
Dentsply Sirona Cerec Guides (K190059)
Stryker Mandibular Fracture and Reconstruction Fixation System, Bone Fixation Screws (K014263)

Related Devices

K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) · Neocis, Inc. · May 8, 2020
K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS) · Neocis, Inc. · Dec 15, 2020
K173402 — Neocis Guidance System (NGS) with Chairside Splint · Neocis, Inc. · Feb 22, 2018
K191605 — Neocis Guidance System (NGS) · Neocis, Inc. · Sep 11, 2019
K161399 — Neocis Guidance System · Neocis, Inc. · Dec 22, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. July 28, 2020 Neocis Inc. Thomas E. Claiborne, Ph.D. Regulatory Affairs Manager 2800 Biscayne Blvd. Suite 600 Miami, Florida 33137 Re: K200805 Trade/Device Name: Neocis Guidance System (NGS) with Patient Splints Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: April 28, 2020 Received: April 29, 2020 Dear Thomas E. Claiborne: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200805 Device Name Neocis Guidance System (NGS) with Patient Splints Indications for Use (Describe) The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous adult patients who qualify for dental implants. Type of Use (Select one or both, as applicable) | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a horizontal gray line that extends over the "neo" part of the word. A vertical gray line intersects the horizontal line above the "c" in "neocis", forming a plus sign with a small circle at the intersection. #### 510(k) Summary #### I. Submitter Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS Contact Person: Thomas E. Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: July 27, 2020 #### II. Device | Trade Name: | Neocis Guidance System (NGS) with Patient Splints | |----------------------|-----------------------------------------------------------| | Common Name: | Dental Stereotaxic Instrument | | Classification Name: | Bone cutting instrument and accessories (21 CFR 872.4120) | | Classification: | Class II | | Product Code: | PLV | #### III. Predicate Devices - X-Guide Surgical Navigation System (K150222) ● #### IV. Reference Devices - Neocis Chairside Splint (K173402) - . Dentsply Sirona Cerec Guides (K190059) - . Stryker Mandibular Fracture and Reconstruction Fixation System, Bone Fixation Screws (K014263) ### V. Indications for Use The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. ### VI. Device Description The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument. The implant process occurs in two phases. First, the dental surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the word is a thin gray horizontal line that extends beyond the letters on both sides. A thin gray vertical line intersects the horizontal line at a small gray circle above the "i" in "neocis". The patient tracking portion of the NGS is comprised of linkages from the NGS, which include the Chairside Patient Splint (CPS) (K173402), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy. The subject of this submission is our Edentulous Patient Splint (EPS). The EPS is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients. ### VII. Comparison of Technological Characteristics This submission includes changes to the indications for use and a new patient splint for use in partially edentulous and fully edentulous patients. There are no changes to the NGS hardware or software in this submission. Since the NGS (K161399) was previously found to be substantially equivalent to K150222, we refer to our prior clearance for a full technological comparison. We have selected K150222 again as a predicate device because we now have technology that allows us to match its performance requirements for fully edentulous patients, which is the focus of this submission. The differences introduced by this modification are detailed in Table 1: Comparison of technological characteristics to the predicates below. {5}------------------------------------------------ Image /page/5/Picture/6 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line, and to the right of the word is a gray vertical line with a circle at the top. | Technologic al Characterist ics | NGS with Patient Splints Subject Device | X-Guide Surgical Navigation System Predicate Device (K150222) | Reference Device-CPS K173402 | Reference Device- Sleeves K190059 | Reference Device- Screws K014263 | SE Analysis | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Indications for Use (IFU) | The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre- operative) and the surgical (intra- operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. | The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra- operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who require dental implants as part of their treatment plan. | The Neocis Guidance System (NGS) is a computerize d navigational system intended to provide assistance in both the planning (pre- operative) and the surgical (intra- operative) phases of dental implantation surgery. The system provides software to preoperative ly plan dental implantation procedures and provides navigational guidance of the surgical instruments. | N/A | N/A | Added condition and patient population from predicate. | | Technologic al Characterist ics | NGS with Patient Splints Subject Device | X-Guide Surgical Navigation System Predicate Device (K150222) | Reference Device-CPS K173402 | Reference Device- Sleeves K190059 | Reference Device- Screws K014263 | SE Analysis | | Contraindication s | The Neocis Guidance System is not intended for use with patients that have insufficient bone to retain a Neocis Edentulous Patient Splint (EPS) rigidly throughout a surgical procedure. The EPS should not be affixed to patients that exhibit: •Patients with insufficient bone quality •Patients with a history of jaw or TMJ pain | Medical conditions which contraindicate the use of X-Guide and its associated applications include any medical conditions which may contraindicate the medical procedure itself. Only for those where dental implants are appropriate & patient is healthy. • Not for use with patients less than 21 years of age. • Not for use with photosensitive epileptic patients. Patient sensitivity may be caused from the LEDs. | The Neocis Guidance System is not intended for use with patients that have insufficien t bone to retain a Neocis Edentulou s Patient Splint (EPS) rigidly throughout a surgical procedure. The EPS should not be affixed to patients that exhibit: Patients with insufficien t bone quality Patients with a history of jaw or TMJ pain Patients with allergies to acrylates | N/A | N/A | Adjusted for EPS. Acrylic-like dental materials are not used with the EPS. Similar to X- Guide. | | Patient Contacting Materials | • Ixef®- HC-1022 • Stainless Steel • Titanium Alloy | • Stainless Steel • Titanium Alloy | IXEF | Stainless Steel | Titanium | Addition of predicate materials | | NGS Power Supply | 120VAC/60 Hz | 120VAC/60Hz | Same as the subject device | N/A | N/A | Same | | Type of Protection against Electric Shock | Class I Equipment | Class I Equipment | Same as the subject device | N/A | N/A | Same | | Technologic al Characterist ics | NGS with Patient Splints Subject Device | X-Guide Surgical Navigation System Predicate Device (K150222) | Reference Device-CPS K173402 | Reference Device- Sleeves K190059 | Reference Device- Screws K014263 | SE Analysis | | Equipment Suitable for use in the presence of Flammable Mixtures? | No | No | N Same as the subject device /A | N/A | N/A | Same | | Electrical Safety | ANSI AAMI ES60601- 1:2005/(R)2012 and A1:2012, C1:2009/(R)20 12 and A2:2010/(R)20 12 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005, MOD) | ANSI AAMI ES60601- 1:2005/(R)2012 and A1:2012,C1:2009/(R) 2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | Same as the subject device | N/A | N/A | Same | | Electromagneti c Disturbances | IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagneti c disturbances . Requirements and tests | IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Same as the subject device | N/A | N/A | Same | | Ingres S Protec tion | IPX0 | IPX2 | Same as the subject device | N/A | N/A | The X-Guide has a higher IPX rating. NGS is 0 because of our draping. | | Mode of Opera tion | Continuous Operation | Continuous Operation | Same as the subject device | N/A | N/A | Same | | System Lateral Accuracy | RMS < 1 mm | RMS < 1 mm | Same as the subject device | N/A | N/A | Same | | Technologic al Characterist ics | NGS with Patient Splints Subject Device | X-Guide Surgical Navigation System Predicate Device (K150222) | Reference Device-CPS K173402 | Reference Device- Sleeves K190059 | Reference Device- Screws K014263 | SE Analysis | | System Depth Accuracy | RMS < 1 mm | RMS < 1 mm | Same as the subject device | N/A | N/A | Same | | System Angular Accuracy | RMS < 6.0° | --- | Same as the subject device | N/A | N/A | Same | | CT Scan Quality Requirement S | 0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512 x 512, Full 13 cm 21 sec. Multi 2 DICOM format. | --- | Same as the subject device | N/A | N/A | NGS has tighter tolerances than X-Guide. | | F/T Sensor Force Measurement Range | +/- 30 N | N/A | Same as the subject device | N/A | N/A | The X-Guide does not use F/T sensors | | F/T Sensor Torque Measurement Ra nge | +/- 2 Nm | N/A | Same as the subject device | N/A | N/A | The X-Guide does not use F/T sensors | | F/T Sensor Single Axis Force Overload Limit | 200 N | N/A | Same as the subject device | N/A | N/A | The X-Guide does not use F/T sensors | | F/T Sensor Single Axis Torque Overload Limit | 20 Nm | N/A | Same as the subject device | N/A | N/A | The X-Guide does not use F/T sensors | | Upper limit specification for Guidance Arm Translation Speed | 1.25 m/s | N/A | Same as the subject device | N/A | N/A | The X-Guide does not have a guidance arm. | | Storage Requirem ents | Store powered at Room Temperature (68°F to 76°F or 20°C to 24.4°C) and standard ambient humidity (5% to 95%) in a dust free, clean environment. | -20 to 60 °C, 10-95% humidity | Same as the subject device | N/A | N/A | Same | | Technologic al Characterist ics | NGS with Patient Splints Subject Device | X-Guide Surgical Navigation System Predicate Device (K150222) | Reference Device-CPS K173402 | Reference Device- Sleeves K190059 | Reference Device- Screws K014263 | SE Analysis | | Patient Tracking | Physical linkage to patient via Patient Tracker and Kinematic Mount connected to: · EPS. or • CPS (K173402 ) | Stereo-LED Optical tracking of: • E-clip • Tracker Arm · X-Corner Patient Tracker | Same as the subject device with CPS | N/A | N/A | Addition of EPS to NGS workflow, which is SE to the X- Guide E-clip. | | Affixation of tracking technology to patient | · EPS with sleeves and bone screws · CPS with dental materia ls (K1827 76) | Metal strip (stainless steel or titanium bone fixation plate) and titanium bone screws | Dental Materi als | Slee ves | Screws and screwdri ver | Same methods for subject device and predicate device using reference devices for implementa tion | | Patient attachment removal | · CPS can be removed manually or by powered cutting tool • EPS is removed by unscrewi ng the bone screws | The metal strip is removed by unscrewing the bone screws | Standard dental techniques | N/A | Use of screwdriver | Addition of predicate removal techniques and reference device implementation | | Fiducials | Fiducial Array (FA) attached to splint | X-clip fiducial attached to patient's teeth or organic fiducials in patient's bone | Same as the Subject Device | N/A | N/A | NGS Fiducial is not patient contacting | | Kinematic mount | Integrated into the splint | E-Clip tracker arm slot integrated into metal strip (bone plate) | KM as separate part | N/A | N/A | Similar implementation | | Biocompatibility | Yes (ISO 10993-1, -5, - 10, -12) | Yes (ISO 10993-1, -5, -10, -11,-12) | Yes (ISO 10993-1, -5, -10, -12) | Yes (ISO 10993-1, - 5, -10, - 12) | Yes (ISO 10993-1, -5, - 10, -12) | Same | | Technologic al Characterist ics | NGS with Patient Splints Subject Device | X-Guide Surgical Navigation System Predicate Device (K150222) | Reference Device-CPS K173402 | Reference Device- Sleeves K190059 | Reference Device- Screws K014263 | SE Analysis | | Sterili…

Neocis Guidance System (NGS) with Patient Splints

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Neocis Guidance System (NGS) with Patient Splints

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!