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FDA 510(k)

STINGRAY CERVICAL CAGE

K-Number: K122085 · 2012-10-17

ApplicantOmni Surgical, LP Dba Spine360
Decision Date2012-10-17
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STINGRAY CERVICAL CAGE is the device name listed in this FDA 510(k) record. The listed applicant is Omni Surgical, LP Dba Spine360. It received FDA 510(k) clearance on 2012-10-17 under 510(k) number K122085. 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 STINGRAY CERVICAL CAGE?

STINGRAY CERVICAL CAGE is a medical device that received FDA 510(k) clearance on 2012-10-17. The listed applicant is Omni Surgical, LP Dba Spine360. The 510(k) number is K122085.

When did STINGRAY CERVICAL CAGE receive FDA 510(k) clearance?

STINGRAY CERVICAL CAGE received FDA 510(k) clearance on 2012-10-17, under 510(k) number K122085.

Who is the listed applicant for STINGRAY CERVICAL CAGE?

The FDA 510(k) record lists Omni Surgical, LP Dba Spine360 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STINGRAY CERVICAL CAGE?

The FDA product code for STINGRAY CERVICAL CAGE is ODP.

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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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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.

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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