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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 the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2017-07-03 under 510(k) 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. The listed applicant is Osseus Fusion Systems, LLC. The 510(k) number is K170844.

When did Gemini-C Hybrid Cervical Interbody System receive FDA 510(k) clearance?

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

Who is the listed applicant for Gemini-C Hybrid Cervical Interbody System?

The FDA 510(k) record lists Osseus Fusion Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Osseus Fusion Systems, LLC as applicant

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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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