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FDA 510(k)

UHMWPE COMPONENTS-CHANGE IN PACKAGING

K-Number: K940743 · 1995-09-18

ApplicantDepuy, Inc.
Decision Date1995-09-18
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UHMWPE COMPONENTS-CHANGE IN PACKAGING is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1995-09-18 under 510(k) number K940743. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UHMWPE COMPONENTS-CHANGE IN PACKAGING?

UHMWPE COMPONENTS-CHANGE IN PACKAGING is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Depuy, Inc.. The 510(k) number is K940743.

When did UHMWPE COMPONENTS-CHANGE IN PACKAGING receive FDA 510(k) clearance?

UHMWPE COMPONENTS-CHANGE IN PACKAGING received FDA 510(k) clearance on 1995-09-18, under 510(k) number K940743.

Who is the listed applicant for UHMWPE COMPONENTS-CHANGE IN PACKAGING?

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

What is the FDA product code for UHMWPE COMPONENTS-CHANGE IN PACKAGING?

The FDA product code for UHMWPE COMPONENTS-CHANGE IN PACKAGING is KWY.

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Other records listing Depuy, Inc. 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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Related Devices (Code: KWY)

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.

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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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