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FDA 510(k)

GKS PRIME FLEX CR TOTAL KNEE SYSTEM

K-Number: K122975 · 2012-12-20

ApplicantPermedica
Decision Date2012-12-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GKS PRIME FLEX CR TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Permedica. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K122975. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GKS PRIME FLEX CR TOTAL KNEE SYSTEM?

GKS PRIME FLEX CR TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Permedica. The 510(k) number is K122975.

When did GKS PRIME FLEX CR TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

GKS PRIME FLEX CR TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2012-12-20, under 510(k) number K122975.

Who is the listed applicant for GKS PRIME FLEX CR TOTAL KNEE SYSTEM?

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

What is the FDA product code for GKS PRIME FLEX CR TOTAL KNEE SYSTEM?

The FDA product code for GKS PRIME FLEX CR TOTAL KNEE SYSTEM is JWH.

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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.

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