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FDA 510(k)

KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM

K-Number: K901338 · 1990-05-22

ApplicantKirschner Medical Corp.
Decision Date1990-05-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

KIRSCHNER MODULAR TCIV TOTAL 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 1990-05-22 under 510(k) number K901338. 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 KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM?

KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K901338.

When did KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1990-05-22, under 510(k) number K901338.

Who is the listed applicant for KIRSCHNER MODULAR TCIV TOTAL 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 MODULAR TCIV TOTAL KNEE SYSTEM?

The FDA product code for KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM is JWH.

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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: 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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