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FDA 510(k)

Sapphire Cervical Implant System

K-Number: K172674 · 2017-11-02

ApplicantSapphire Medical Group
Decision Date2017-11-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sapphire Cervical Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Sapphire Medical Group. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K172674. 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 Sapphire Cervical Implant System?

Sapphire Cervical Implant System is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Sapphire Medical Group. The 510(k) number is K172674.

When did Sapphire Cervical Implant System receive FDA 510(k) clearance?

Sapphire Cervical Implant System received FDA 510(k) clearance on 2017-11-02, under 510(k) number K172674.

Who is the listed applicant for Sapphire Cervical Implant System?

The FDA 510(k) record lists Sapphire Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sapphire Cervical Implant System?

The FDA product code for Sapphire Cervical Implant System is ODP.

Other records listing Sapphire Medical Group as applicant

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.

K232619MATRIX HA PEEK Cervical IBF SystemK192316Matrix HA PEEK Cervical Implant SystemK183073SMG Anterior Cervical Plate System

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

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

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