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FDA 510(k)

KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD

K-Number: K862057 · 1986-07-11

ApplicantKirschner Medical Corp.
Decision Date1986-07-11
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD 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 1986-07-11 under 510(k) number K862057. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD?

KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K862057.

When did KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD receive FDA 510(k) clearance?

KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862057.

Who is the listed applicant for KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD?

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 UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD?

The FDA product code for KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD is KWY.

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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: KWY)

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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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