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FDA 510(k)

ANYPLUS PEEK CAGES

K-Number: K100516 · 2010-12-03

ApplicantGS Medical Co., Ltd.
Decision Date2010-12-03
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANYPLUS PEEK CAGES is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K100516. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANYPLUS PEEK CAGES?

ANYPLUS PEEK CAGES is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K100516.

When did ANYPLUS PEEK CAGES receive FDA 510(k) clearance?

ANYPLUS PEEK CAGES received FDA 510(k) clearance on 2010-12-03, under 510(k) number K100516.

Who is the listed applicant for ANYPLUS PEEK CAGES?

The FDA 510(k) record lists GS Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANYPLUS PEEK CAGES?

The FDA product code for ANYPLUS PEEK CAGES is OVD.

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Other records listing GS Medical Co., Ltd. as applicant

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Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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