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FDA 510(k)

KIRSCHNER BONE FIXATION FASTENER SYSTEM

K-Number: K854445 · 1985-11-19

ApplicantKirschner Medical Corp.
Decision Date1985-11-19
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER BONE FIXATION FASTENER 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 1985-11-19 under 510(k) number K854445. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRSCHNER BONE FIXATION FASTENER SYSTEM?

KIRSCHNER BONE FIXATION FASTENER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K854445.

When did KIRSCHNER BONE FIXATION FASTENER SYSTEM receive FDA 510(k) clearance?

KIRSCHNER BONE FIXATION FASTENER SYSTEM received FDA 510(k) clearance on 1985-11-19, under 510(k) number K854445.

Who is the listed applicant for KIRSCHNER BONE FIXATION FASTENER 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 BONE FIXATION FASTENER SYSTEM?

The FDA product code for KIRSCHNER BONE FIXATION FASTENER SYSTEM is JDR.

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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: JDR)

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K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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