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FDA 510(k)

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

K-Number: K854107 · 1986-03-10

ApplicantKirschner Medical Corp.
Decision Date1986-03-10
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED 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 1986-03-10 under 510(k) number K854107. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DIMENSION TOTAL HIP PROSTHESIS POROUS COATED?

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K854107.

When did DIMENSION TOTAL HIP PROSTHESIS POROUS COATED receive FDA 510(k) clearance?

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED received FDA 510(k) clearance on 1986-03-10, under 510(k) number K854107.

Who is the listed applicant for DIMENSION TOTAL HIP PROSTHESIS POROUS COATED?

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 TOTAL HIP PROSTHESIS POROUS COATED?

The FDA product code for DIMENSION TOTAL HIP PROSTHESIS POROUS COATED 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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