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FDA 510(k)

KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM

K-Number: K894068 · 1989-12-08

ApplicantKirschner Medical Corp.
Decision Date1989-12-08
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kirschner Medical Corp.. It received FDA 510(k) clearance on 1989-12-08 under 510(k) number K894068. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM?

KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-08. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K894068.

When did KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM receive FDA 510(k) clearance?

KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance on 1989-12-08, under 510(k) number K894068.

Who is the listed applicant for KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM?

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

What is the FDA product code for KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM?

The FDA product code for KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM is HSX.

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Other records listing Kirschner Medical Corp. 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.

K940537KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEMK936274KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEMK942891SUMMIT TOTAL HIP SYSTEMK941486INTEGRITY TOTAL HIP SYSTEM, NON-POROUSK933843LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATEDK935951KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM

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Related Devices (Code: HSX)

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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

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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