FDA 510(k)

HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR

K-Number: K965164 · 1997-03-13

Decision Date1997-03-13

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K965164. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR?

HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Howmedica Corp.. The 510(k) number is K965164.

When did HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR receive FDA 510(k) clearance?

HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR received FDA 510(k) clearance on 1997-03-13, under 510(k) number K965164.

Who is the listed applicant for HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR?

The FDA product code for HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR is LPH.

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Other records listing Howmedica Corp. as applicant

K983528MICRO DYNAMIC MESH K983404TYPE 3 FEMORAL COMPONENTS K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION K980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION K980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.