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FDA 510(k)

DIMENSION REVISION TOTAL HIP SYSTEM

K-Number: K895636 · 1989-12-14

ApplicantKirschner Medical Corp.
Decision Date1989-12-14
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DIMENSION REVISION TOTAL HIP 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 1989-12-14 under 510(k) number K895636. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DIMENSION REVISION TOTAL HIP SYSTEM?

DIMENSION REVISION TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K895636.

When did DIMENSION REVISION TOTAL HIP SYSTEM receive FDA 510(k) clearance?

DIMENSION REVISION TOTAL HIP SYSTEM received FDA 510(k) clearance on 1989-12-14, under 510(k) number K895636.

Who is the listed applicant for DIMENSION REVISION TOTAL HIP 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 DIMENSION REVISION TOTAL HIP SYSTEM?

The FDA product code for DIMENSION REVISION TOTAL HIP SYSTEM 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)

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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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