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FDA 510(k)

AGC UNICOMPARTMENTAL KNEE PROSTHESIS

K-Number: K873601 · 1988-01-20

ApplicantBiomet, Inc.
Decision Date1988-01-20
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGC UNICOMPARTMENTAL KNEE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1988-01-20 under 510(k) number K873601. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGC UNICOMPARTMENTAL KNEE PROSTHESIS?

AGC UNICOMPARTMENTAL KNEE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1988-01-20. The listed applicant is Biomet, Inc.. The 510(k) number is K873601.

When did AGC UNICOMPARTMENTAL KNEE PROSTHESIS receive FDA 510(k) clearance?

AGC UNICOMPARTMENTAL KNEE PROSTHESIS received FDA 510(k) clearance on 1988-01-20, under 510(k) number K873601.

Who is the listed applicant for AGC UNICOMPARTMENTAL KNEE PROSTHESIS?

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 UNICOMPARTMENTAL KNEE PROSTHESIS?

The FDA product code for AGC UNICOMPARTMENTAL KNEE PROSTHESIS is HRY.

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Other records listing Biomet, Inc. as applicant

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.

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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