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FDA 510(k)

AGC REVISION KNEE PROTHESIS

K-Number: K912245 · 1991-08-19

ApplicantBiomet, Inc.
Decision Date1991-08-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

AGC REVISION KNEE PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1991-08-19 under 510(k) number K912245. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AGC REVISION KNEE PROTHESIS?

AGC REVISION KNEE PROTHESIS is a medical device that received FDA 510(k) clearance on 1991-08-19. The listed applicant is Biomet, Inc.. The 510(k) number is K912245.

When did AGC REVISION KNEE PROTHESIS receive FDA 510(k) clearance?

AGC REVISION KNEE PROTHESIS received FDA 510(k) clearance on 1991-08-19, under 510(k) number K912245.

Who is the listed applicant for AGC REVISION KNEE PROTHESIS?

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

What is the FDA product code for AGC REVISION KNEE PROTHESIS?

The FDA product code for AGC REVISION KNEE PROTHESIS is JWH.

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) 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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