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FDA 510(k)

KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM

K-Number: K882241 · 1988-06-29

ApplicantKirschner Medical Corp.
Decision Date1988-06-29
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER (R) UNICONDYLAR-II 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 1988-06-29 under 510(k) number K882241. 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 KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM?

KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-06-29. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K882241.

When did KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM receive FDA 510(k) clearance?

KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM received FDA 510(k) clearance on 1988-06-29, under 510(k) number K882241.

Who is the listed applicant for KIRSCHNER (R) UNICONDYLAR-II 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 (R) UNICONDYLAR-II KNEE SYSTEM?

The FDA product code for KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM is HRY.

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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: 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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