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FDA 510(k)

UNICONDYLAR FIBER METAL KNEE

K-Number: K834298 · 1984-02-13

ApplicantZimmer, Inc.
Decision Date1984-02-13
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNICONDYLAR FIBER METAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1984-02-13 under 510(k) number K834298. 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 UNICONDYLAR FIBER METAL KNEE?

UNICONDYLAR FIBER METAL KNEE is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is Zimmer, Inc.. The 510(k) number is K834298.

When did UNICONDYLAR FIBER METAL KNEE receive FDA 510(k) clearance?

UNICONDYLAR FIBER METAL KNEE received FDA 510(k) clearance on 1984-02-13, under 510(k) number K834298.

Who is the listed applicant for UNICONDYLAR FIBER METAL KNEE?

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

What is the FDA product code for UNICONDYLAR FIBER METAL KNEE?

The FDA product code for UNICONDYLAR FIBER METAL KNEE is HRY.

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Other records listing Zimmer, Inc. as applicant

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K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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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