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FDA 510(k)

Gemini-C Hybrid Cervical Interbody System

K-Number: K170844 · 2017-07-03

ApplicantOsseus Fusion Systems, LLC
Decision Date2017-07-03
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gemini-C Hybrid Cervical Interbody System is a medical device manufactured by Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2017-07-03 under approval number K170844. 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 Gemini-C Hybrid Cervical Interbody System?

Gemini-C Hybrid Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2017-07-03. It is manufactured by Osseus Fusion Systems, LLC. The 510(k) number is K170844.

When was Gemini-C Hybrid Cervical Interbody System approved by the FDA?

Gemini-C Hybrid Cervical Interbody System received FDA 510(k) clearance on 2017-07-03, under approval number K170844.

What company makes Gemini-C Hybrid Cervical Interbody System?

Gemini-C Hybrid Cervical Interbody System is manufactured by Osseus Fusion Systems, LLC.

What is the FDA product code for Gemini-C Hybrid Cervical Interbody System?

The FDA product code for Gemini-C Hybrid Cervical Interbody System is ODP.

Related Clinical Trials

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Related PubMed Literature

PMID: 40563006 Toward Transparent AI-Enabled Patient Selection in Cosmetic Surgery by Integrating Reasoning and Medical LLMs. Aesthetic plastic surgery (2025)

Other Devices by Osseus Fusion Systems, LLC

K160522White Pearl Preferred Angle Anterior Cervical Plate K181347Aries® Lumbar Interbodies K213590Blue Topaz Sacroiliac Screw 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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