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FDA 510(k)

ENHANCED POLYETHYLENE KNEE PROSTHESES

K-Number: K001147 · 2001-02-15

ApplicantHowmedica Osteonics Corp.
Decision Date2001-02-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENHANCED POLYETHYLENE KNEE PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K001147. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENHANCED POLYETHYLENE KNEE PROSTHESES?

ENHANCED POLYETHYLENE KNEE PROSTHESES is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K001147.

When did ENHANCED POLYETHYLENE KNEE PROSTHESES receive FDA 510(k) clearance?

ENHANCED POLYETHYLENE KNEE PROSTHESES received FDA 510(k) clearance on 2001-02-15, under 510(k) number K001147.

Who is the listed applicant for ENHANCED POLYETHYLENE KNEE PROSTHESES?

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

What is the FDA product code for ENHANCED POLYETHYLENE KNEE PROSTHESES?

The FDA product code for ENHANCED POLYETHYLENE KNEE PROSTHESES is JWH.

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Related Devices (Code: JWH)

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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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