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FDA 510(k)

KM-2 METAL-BACKED ACETABULAR CUP

K-Number: K844319 · 1985-09-19

ApplicantKirschner Medical Corp.
Decision Date1985-09-19
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

KM-2 METAL-BACKED ACETABULAR CUP 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 1985-09-19 under 510(k) number K844319. 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 KM-2 METAL-BACKED ACETABULAR CUP?

KM-2 METAL-BACKED ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K844319.

When did KM-2 METAL-BACKED ACETABULAR CUP receive FDA 510(k) clearance?

KM-2 METAL-BACKED ACETABULAR CUP received FDA 510(k) clearance on 1985-09-19, under 510(k) number K844319.

Who is the listed applicant for KM-2 METAL-BACKED ACETABULAR CUP?

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 KM-2 METAL-BACKED ACETABULAR CUP?

The FDA product code for KM-2 METAL-BACKED ACETABULAR CUP 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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