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FDA 510(k)

MODULAR FEMORAL HEAD WITH OFFSET TRUNION

K-Number: K914675 · 1992-08-07

ApplicantKirschner Medical Corp.
Decision Date1992-08-07
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR FEMORAL HEAD WITH OFFSET TRUNION 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 1992-08-07 under 510(k) number K914675. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR FEMORAL HEAD WITH OFFSET TRUNION?

MODULAR FEMORAL HEAD WITH OFFSET TRUNION is a medical device that received FDA 510(k) clearance on 1992-08-07. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K914675.

When did MODULAR FEMORAL HEAD WITH OFFSET TRUNION receive FDA 510(k) clearance?

MODULAR FEMORAL HEAD WITH OFFSET TRUNION received FDA 510(k) clearance on 1992-08-07, under 510(k) number K914675.

Who is the listed applicant for MODULAR FEMORAL HEAD WITH OFFSET TRUNION?

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 MODULAR FEMORAL HEAD WITH OFFSET TRUNION?

The FDA product code for MODULAR FEMORAL HEAD WITH OFFSET TRUNION is JDI.

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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: JDI)

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.

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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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