FDA 510(k)

GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)

K-Number: K111354 · 2011-10-17

Decision Date2011-10-17

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) 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 2011-10-17 under 510(k) number K111354. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)?

GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K111354.

When did GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) receive FDA 510(k) clearance?

GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) received FDA 510(k) clearance on 2011-10-17, under 510(k) number K111354.

Who is the listed applicant for GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)?

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 GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)?

The FDA product code for GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) is MAX.

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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.