FDA 510(k)

HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS

K-Number: K951115 · 1995-06-16

Decision Date1995-06-16

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-06-16 under 510(k) number K951115. 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 VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS?

HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS is a medical device that received FDA 510(k) clearance on 1995-06-16. The listed applicant is Howmedica Corp.. The 510(k) number is K951115.

When did HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS receive FDA 510(k) clearance?

HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS received FDA 510(k) clearance on 1995-06-16, under 510(k) number K951115.

Who is the listed applicant for HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS?

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 VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS?

The FDA product code for HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS 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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Related Devices (Code: LPH)

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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.