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FDA 510(k)

KM-4(TM) METAL-BACKED ACETABULAR CUP

K-Number: K870867 · 1987-05-08

ApplicantKirschner Medical Corp.
Decision Date1987-05-08
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KM-4(TM) 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 1987-05-08 under 510(k) number K870867. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KM-4(TM) METAL-BACKED ACETABULAR CUP?

KM-4(TM) METAL-BACKED ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1987-05-08. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K870867.

When did KM-4(TM) METAL-BACKED ACETABULAR CUP receive FDA 510(k) clearance?

KM-4(TM) METAL-BACKED ACETABULAR CUP received FDA 510(k) clearance on 1987-05-08, under 510(k) number K870867.

Who is the listed applicant for KM-4(TM) 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-4(TM) METAL-BACKED ACETABULAR CUP?

The FDA product code for KM-4(TM) METAL-BACKED ACETABULAR CUP is JDL.

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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: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.

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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