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FDA 510(k)

Kodiak C Spinal Implant System

K-Number: K222806 · 2022-12-22

ApplicantMet One Technologies, LLC
Decision Date2022-12-22
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kodiak C Spinal Implant System is a medical device manufactured by Met One Technologies, LLC. It received FDA 510(k) clearance on 2022-12-22 under approval number K222806. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kodiak C Spinal Implant System?

Kodiak C Spinal Implant System is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Met One Technologies, LLC. The 510(k) number is K222806.

When was Kodiak C Spinal Implant System approved by the FDA?

Kodiak C Spinal Implant System received FDA 510(k) clearance on 2022-12-22, under approval number K222806.

What company makes Kodiak C Spinal Implant System?

Kodiak C Spinal Implant System is manufactured by Met One Technologies, LLC.

What is the FDA product code for Kodiak C Spinal Implant System?

The FDA product code for Kodiak C Spinal Implant System is ODP.

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Related PubMed Literature

PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Met One Technologies, LLC

K230851Kodiak Lumbar Spacer System K250866Sovereign Posterior Cervical System K251732Wrist Fracture System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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