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FDA 510(k)

KIRSCHNER INTRAMEDULLARY NAIL SYSTEM

K-Number: K854338 · 1985-12-09

ApplicantKirschner Medical Corp.
Decision Date1985-12-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER INTRAMEDULLARY NAIL 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 1985-12-09 under 510(k) number K854338. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRSCHNER INTRAMEDULLARY NAIL SYSTEM?

KIRSCHNER INTRAMEDULLARY NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K854338.

When did KIRSCHNER INTRAMEDULLARY NAIL SYSTEM receive FDA 510(k) clearance?

KIRSCHNER INTRAMEDULLARY NAIL SYSTEM received FDA 510(k) clearance on 1985-12-09, under 510(k) number K854338.

Who is the listed applicant for KIRSCHNER INTRAMEDULLARY NAIL 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 INTRAMEDULLARY NAIL SYSTEM?

The FDA product code for KIRSCHNER INTRAMEDULLARY NAIL SYSTEM is HSB.

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Other records listing Kirschner Medical Corp. as applicant

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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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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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