Who is the manufacturer of OsteoMed ExtremiFix Mini & Small System Tray?

Osteomed, LLC filed the 510(k) submission for OsteoMed ExtremiFix Mini & Small System Tray (K202105).

What is the FDA product code for OsteoMed ExtremiFix Mini & Small System Tray?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for OsteoMed ExtremiFix Mini & Small System Tray?

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

Who can help prepare an FDA 510(k) submission like OsteoMed ExtremiFix Mini & Small System Tray?

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.

OsteoMed ExtremiFix Mini & Small System Tray

Q: What are the predicate devices for OsteoMed ExtremiFix Mini & Small System Tray?

OsteoMed MMF Sterilization Tray (K173391).

K202105 · Osteomed, LLC · KCT · Oct 29, 2020 · General Hospital

Device Facts

Record ID	K202105
Device Name	OsteoMed ExtremiFix Mini & Small System Tray
Applicant	Osteomed, LLC
Product Code	KCT · General Hospital
Decision Date	Oct 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre-vacum) steam sterilization methods. The system tray is not intended to maintain sterlity; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container.

Device Story

System tray for organizing, storing, and sterilizing OsteoMed ExtremiFix Mini & Small implants and surgical instruments. Comprised of outer case, screw modules, and instrument trays. Perforated design allows steam penetration during pre-vacuum autoclave cycles. Used in hospital/healthcare facilities; operated by sterile processing staff or surgical personnel. Provides protection and organization during sterilization, transport, and storage. Requires external FDA-cleared wrap or rigid container to maintain sterility post-process. Benefits include standardized, validated sterilization workflow for specific implant sets.

Clinical Evidence

Bench testing only. No clinical or animal studies performed. Testing included sterilization validation (wrapped and rigid container configurations), cleaning validation (AAMI TIR 12/30), shipping testing (ASTM D-4169), reliability verification (100 cycles), and biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation, pyrogen testing).

Technological Characteristics

Materials: anodized/non-anodized aluminum, stainless steel, silicone, PET (Mylar), polyphenylsulfone (Radel), polyamide 11 (nylon), ZEUS PFA. Perforated aluminum tray system. Energy source: steam autoclave. Connectivity: none. Sterilization: pre-vacuum steam (270°F/132°C, 4 min exposure).

Indications for Use

Indicated for containing Mini and Small implants and surgical instruments for sterilization, storage, and handling in hospital environments. Not intended to maintain sterility independently; must be used with FDA-cleared sterilization wrap or rigid container. Max load 14.1 lbs.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

OsteoMed MMF Sterilization Tray (K173391)

Reference Devices

NuVasive Sterilization Tray (K143579)

Related Devices

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K102103 — SKELETAL DYNAMICS STERILIZATION TRAYS · Skeletal Dynamics, LLC · Dec 7, 2010
K183701 — Stryker ChestShield Sterilization Tray System · Paragon Medical · May 7, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 29, 2020 OsteoMed LLC Andrew Johnson Senior Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001 Re: K202105 Trade/Device Name: OsteoMed ExtremiFix Mini & Small System Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 28, 2020 Received: July 31, 2020 ## Dear Andrew Johnson: 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 prohibitions 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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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 Kapil Panguluri, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202105 Device Name OsteoMed ExtremiFix Mini & Small System Tray ### Indications for Use (Describe) The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre- vacum) steam sterilization methods. The system tray is not intended to maintain sterlity; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container. Sterilization was performed utilizing the ExtremlFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray. Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a wrapped configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 50 minutes Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a rigid container configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### 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/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue stripe at the top and a gray stripe at the bottom. The word "OSTEOMED" is written in blue and gray in the center of the oval. The logo is simple and modern. # K202105 510(k) SUMMARY #### I. SUBMITTER OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA Phone: 972-677-4795 Fax: 972-677-4601 Email: djohnson@osteomed.com Contact Person: Drew Johnson Date Prepared: 7/28/2020 #### II. DEVICE Name of the Device: OsteoMed ExtremiFix Mini & Small System Tray Common or Usual Name: Sterilization Tray Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Regulation: 880.6850 Regulatory Class: II Product Code: KCT #### III. PREDICATE DEVICE Predicate Device: OsteoMed MMF Sterilization Tray (K173391) Reference Device: NuVasive Sterilization Tray (K143579) #### IV. DEVICE DESCRIPTION The OsteoMed ExtremiFix Mini & Small System Tray is composed of anodized and non-anodized aluminum, stainless steel, silicone, polyethylene terephthalate (Mylar), polyphenylsulfone (Radel), polyamide 11 (nylon), and ZEUS Perfluoroalkoxy (PFA), which are common tray materials, and is used to enclose, protect, and organize OsteoMed ExtremiFix Mini & Small System implants and surgical instruments. This is a product specific sterilization storage system tray (only for use with the OsteoMed ExtremiFix Mini & Small System) that is intended to provide storage for the OsteoMed ExtremiFix screws and accessories during sterilization, storage, and transportation within the hospital environment. The OsteoMed ExtremiFix Mini & Small System Tray is a single sterilization storage system that is comprised of one outer case (base + lid), two screw modules {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue stripe on the top and a gray stripe on the bottom. The word "OSTEOMED" is written in blue letters in the center of the oval. The logo is simple and modern. (any two of the four sizes), and two trays (handle tray + instrument tray). The trays are perforated to allow for steam sterilization. An FDA-cleared wrap or FDAcleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed ExtremiFix Mini & Small SystemTray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed ExtremiFix Mini & Small System Tray is effective for containing the system devices during sterilization and have been designed to withstand repeated steam sterilization cycles. #### V. INDICATIONS FOR USE The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (prevacuum) steam sterilization methods. The system tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container. Sterilization validation was performed utilizing the ExtremiFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray. Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a wrapped configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 50 minutes Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a rigid container configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue top and a gray bottom. The word "OSTEOMED" is written in bold, sans-serif font across the center of the oval, with "OSTEO" in blue and "MED" in gray. There is a registered trademark symbol in the upper right corner of the oval. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE Provided in the table below is the OsteoMed ExtremiFix Mini & Small System Tray and the comparison with the predicate. | Characteristics | Subject Device: OsteoMed ExtremiFix Mini & Small System Tray | Predicate Device: OsteoMed QuickFix Hybrid MMF Sterilization Tray (K173391) | Comparison | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Product Code | KCT | KCT | Same | | 21 CFR | 888.685 | 888.685 | Same | | System Components | Base, lid, screw modules, instrument trays | Base, lid, locking latch | Similar | | Material Composition | Aluminum, stainless steel, silicone, polyethylene terephthalate, nylon, polyphenylsulfone, ZEUS Perfluoroalkoxy | Aluminum | Similar | | Physical Properties | Evenly distributed perforated hole pattern | Evenly distributed perforated hole pattern | Same | | Configurations/Dimensions (L x W x H) in. | Outer case: 17.6 x 9.5 x 4.1 Screw modules: 8.1 x 6.1 x 3.3 Instrument trays: 9.2 x 3.3 x 1.6 | Rectangle base with lid: 9.5 x 5.0 x 1.5 | Similar | | Sterilant Penetration | Sterilant (steam) penetration through perforations in tray | Sterilant (steam) penetration through perforations in tray | Same | | Sterilization method | Steam | Steam | Same | | Sterilization cycle | Pre-vacuum | Pre-vacuum | Same | | Exposure temperature | 270°F (132°C) | 270°F (132°C) | Same | | Exposure time | 4 minutes | 4 minutes | Same | | Dry time | 30 minutes (rigid container) 50 minutes (wrapped) | 30 minutes | Similar | | Reusable | Yes | Yes | Same | | Vent to Volume Ratio | Outer case: 0.231 in2/in3 Module: 0.260 in2/in3 | Base/lid: 0.050 in2/in3 | Similar | | Worse Case Lumen | T7 driver long: Ø0.038, L = 0.371" (1 ea.) T10 driver long: Ø0.050, length 5" (1 ea.) 2.0mm module screw hole: Ø0.092, length 0.325" (126 ea.) | Base steam hole: Ø0.094, length 1.075" (1 ea.) Driver sleeve: Ø0.115, length 0.680'' Driver handle: blind hole Ø0.111, depth 1.173" | Similar | | Indications for Use | 2.4mm module screw hole: Ø0.105, length 0.325" (150 ea.) | The OsteoMed QuickFix Hybrid MMF Sterilization Tray is intended to contain OsteoMed QuickFix Hybrid MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed QuickFix Hybrid MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDAcleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization trays may also be used in conjunction with a legally marketed rigid container. Sterilization validation was done for the OsteoMed QuickFix Hybrid MMF device and accessories. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray. Validated sterilization parameters for OsteoMed QuickFix Hybrid MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) | Similar | | | 3.0mm module screw hole: Ø0.130, length 0.325" (96 ea.) | | | | | 4.0mm module screw hole: Ø0.165, length 0.325" (108 ea.) | | | | | The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (prevacuum) steam sterilization methods. The system tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA- cleared sterilization wrap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container. | | | | | Sterilization validation was performed utilizing the ExtremiFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray. | | | | | Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a wrapped configuration: | | | | ExtremiFix Mini & Small System Tray in a wrapped configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 50 minutes Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a rigid container configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Minimum Dry Time: 30 minutes | Exposure Time: 4 minutes Minimum Dry Time: 30 minutes | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The logo is surrounded by a gray and blue oval shape. The word "OSTEOMED" is in blue, and the oval shape is gray on the bottom and blue on the top. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The word "OSTEO" is in blue, and the word "MED" is in gray. The logo is surrounded by a blue and gray oval shape. The logo is clean and professional, and it is likely used to represent a medical company. ## SUMMARY OF NON-CLINICAL TESTING The testing provided below was performed to demonstrate whether the subject device met the performance acceptance criteria of the respective standard listed below: ## Biocompatibility Testing A biocompatibility evaluation was conducted according to FDA guidance document "Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process,"" Guidance for Industry and Food and Drug Administration Staff, dated June 16, 2016. The subject device does not have direct contact with patients. The implants and instruments to be sterilized in the subject device will have contact with the subject device's surfaces; therefore, the subject device's case, trays, and modules have indirect contact with the patient. The subject device indirect patient contact materials are similar materials that were previous cleared with the predicate device, K173391, and the reference device, K143579. The subject device met testing requirements for: - Cytotoxicity - Sensitization - Irritation - Pyrogen testing ● {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue top and a gray bottom. The word "OsteoMed" is written in blue and gray inside the oval. There is a registered trademark symbol in the upper right corner of the logo. # Bench Testing The following table provides a summary of the bench testing conducted. | Test Description | Purpose | Acceptance Criteria | Summary of Test Results | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Design Validation | To validate the design and performance of the ExtremiFix Mini & Small System | Surgeons evaluated the functionalit y of the tray. | Pass; met all requirements | | Test Description | Purpose | Acceptance Criteria | Summary of Test Results | | Ship Testing | To establish that the ExtremiFix Mini & Small System, and associated packaging, protects and retains the implants and instruments during normal shipping and handling. | Ship packaged plate per ASTM D-4169 and evaluate package contents for damage upon return. | Pass | | Cleaning Validation (reusable instruments) | To validate the prescribed manual cleaning process for the ExtremiFix Mini & Small System. | Use the T7 cannulated long driver as worst- case device to verify that re- useable instruments can be cleaned per instructions to achieve standard requirements for reusable devices per AAMI TIR 12 and AAMI TIR 30. | Pass | | Sterilization Validation | To validate the steam sterilization parameters for the ExtremiFix Mini & Small System to ensure that the fully-populated system can be sterilized. | Validate sterilization parameters with 3 consecutive tests. Conducted test for both systems wrapped in polypropylene sterile wrap and system enclosed in rigid container. | Passed for both sterile wrap and rigid container configurati ons | | Reliability Verification (Sterilization Cycles Validation) | To assess the reliability, via repeated use and sterilization, of the ExtremiFix Mini & Small System. | Verify functionality and graphics legibility after the system tray is steam sterilized for 100 cycles with the sterilization parameters described in the IFU. | Passed functional and visual criteria after 100 cycles | | Cytotoxicity | The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. | The ANSI/AAMI/ISO 10993-5 standard states that the achievement of a | Pass | | | | | | | | | greater than 2 is considered cytotoxic effect, or a failing score. | | | Sensitization | To determine the potential sensitization effects of subject device indirect contact materials. | The test is considered negative for signs of sensitization if the positive response observed is in less than 10% of the test animals. | Pass | | Irritation | To determine the potential irritation effects of subject device indirect contact materials. | The requirements of the test will be met if the difference between the test article mean score and control mean score is 1.0 or less. | Pass | | Pyrogen testing | The Bacterial Endotoxins Test, or Limulus Amebocyte Lysate (LAL) test, is an in vitro assay to detect and quantify bacterial endotoxin, a component of the cell wall of Gram negative bacteria. | For medical devices, the endotoxin limit is not more than 20.0 EU/device. | Pass | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue top and a gray bottom. The word "OSTEOMED" is written in blue and gray letters across the center of the oval. The logo is simple and modern. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in blue, bold letters. The logo is surrounded by a gray and blue oval. The blue part of the oval is on top, and the gray part is on the bottom. The results on the non-clinical testing demonstrated that the subject device met the acceptance criteria of the standard. ## Animal Study No animal studies were performed to demonstrate safety and efficacy. ### Clinical Studies No clinical studies were performed to demonstrate safety and efficacy. #### CONCLUSIONS VII. The conclusions drawn from the nonclinical tests demonstrate that the OsteoMed ExtremiFix Mini & Small System Tray is as safe, as effective, and performs as well as or better than the legally marketed device OsteoMed MMF Sterilization Tray (K173391) under regulation 21 CFR 880.6850, product code KCT.