← Product Code [KWQ](/productcode/KWQ) · K262149 # corra® cervical plating system (K262149) _Carlsmed, Inc. · KWQ · Sep 24, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K262149 ## Device Facts - **Applicant:** Carlsmed, Inc. - **Product Code:** [KWQ](/productcode/KWQ.md) - **Decision Date:** Sep 24, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The corra® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications:• Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),• Spondylolisthesis,• Trauma (i.e., fracture or dislocation),• Spinal stenosis,• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),• Tumor,• Pseudoarthrosis, and• Failed previous fusion.The corra® cervical plating system is intended to be used in conjunction with the aprevo® cervical interbody system. ## Device Story The corra® cervical plating system provides anterior fixation of the cervical spine (C2-T1). The system consists of patient-specific segmental and multilevel plates and screws; implants are additively manufactured from titanium alloy. The device is used by surgeons in a clinical setting to stabilize the cervical spine in conjunction with the aprevo® cervical interbody system. The system includes associated instruments for placement, adjustment, and removal of implants. The device provides mechanical stabilization to facilitate fusion and address various spinal pathologies. ## Clinical Evidence No clinical data. Substantial equivalence is based on non-clinical mechanical testing (static and dynamic compression bending, static torsion per ASTM F1717) and cadaveric evaluation. ## Technological Characteristics System includes patient-specific segmental and multilevel plates and screws. Materials: Titanium alloy (Ti-4Al-6V ELI) per ASTM F3001 (plates) and ASTM F136 (screws). Instruments: Medical-grade stainless steel and plastics. Manufacturing: Additive manufacturing for implants. Sterilization: Not specified. Connectivity: None. ## Regulatory Identification A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions. ## Predicate Devices - corra® cervical plating system ([K260570](/device/K260570.md)) ## Reference Devices - aprevo® cervical interbody system ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION September 24, 2026 Carlsmed, Inc. Jesse Albright Sr. Manager, Regulatory Affairs 1800 Aston Ave. Suite 100 Carlsbad, California 92008 Re: K262149 Trade/Device Name: corra® cervical plating system Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 21, 2026 Received: August 24, 2026 Dear Jesse Albright: 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 (the 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 available 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. Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262149 - Jesse Albright Page 2 When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K262149 - Jesse Albright Page 3 assistance/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, # MAZIAR SHAH-MOHAMMADI -S Maziar ShahMohammadi, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262149 | ? | | Please provide the device trade name(s). | | ? | | corra® cervical plating system | | | | Please provide your Indications for Use below. | | ? | | The corra® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications:• Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),• Spondylolisthesis,• Trauma (i.e., fracture or dislocation),• Spinal stenosis,• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),• Tumor,• Pseudoarthrosis, and• Failed previous fusion.The corra® cervical plating system is intended to be used in conjunction with the aprevo® cervical interbody system. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} K262149- Page 1 of 2 # 510(k) Summary # Contact Details Applicant: Carlsmed, Inc. Address: 1800 Aston Ave Ste 100 Carlsbad, CA 92008 Phone number: (760) 766-1923 Contact person: Jesse Albright Sr. Manager, Regulatory Affairs jalbright@carlsmed.com Date prepared: August 21, 2026 # Device Name Trade name: corra® cervical plating system Common name: Appliance, Fixation, Spinal Intervertebral Body Classification name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) Class: II Product code: KWQ Legally Marketed Predicate Device | 510(k) Number | Product Code | Trade Name | Manufacturer | | --- | --- | --- | --- | | Primary Predicate Device | | | | | K260570 | KWQ | corra® cervical plating system | Carlsmed, Inc. | # Device Description The corra® cervical plating system, which is comprised of the corra® cervical segmental plating system and the corra® cervical multilevel plating system configurations, is intended for anterior fixation of the cervical spine. The system consists of a variety of patient-specific segmental and multilevel plates that are additively manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F3001 as well as a range of screws manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F136. The associated system instruments, which facilitate the placement, adjustment, and removal, if necessary, of the implants, are manufactured from medical-grade materials, such as stainless steels and plastics. {5} K262149- Page 2 of 2 ## Indications for Use The corra® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications: - Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), - Spondylolisthesis, - Trauma (i.e., fracture or dislocation), - Spinal stenosis, - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - Tumor, - Pseudoarthrosis, and - Failed previous fusion. The corra® cervical plating system is intended to be used in conjunction with the aprevo® cervical interbody system. ## Summary of Technological Characteristics The corra® cervical plating system technological characteristics are substantially equivalent to the cited predicate device. The equivalence determination was based on comparison of intended use/indications for use, technological characteristics (e.g., operating principle, design, components, materials, biocompatibility, manufacturing, packaging, labeling, sterility, etc.), and non-clinical testing. ## Non-Clinical Testing Mechanical testing in static and dynamic compression bending and static torsion was performed in accordance with ASTM F1717 and additional engineering analysis was conducted to demonstrate substantial equivalence of the corra® cervical plating system to predicate devices. Cadaveric evaluation also demonstrated that the subject device performs as intended. ## Clinical Testing Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data. ## Conclusion The submitted data demonstrates that the subject corra® cervical plating system is substantially equivalent to the cited legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/device/K262149](https://fda.innolitics.com/device/K262149) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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