FDA 510(k)

22 MM COCR HEAD & POLYETHLENE LINER

K-Number: K960180 · 1996-05-02

Decision Date1996-05-02

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

22 MM COCR HEAD & POLYETHLENE LINER is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 1996-05-02 under 510(k) number K960180. 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 22 MM COCR HEAD & POLYETHLENE LINER?

22 MM COCR HEAD & POLYETHLENE LINER is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Stelkast Company. The 510(k) number is K960180.

When did 22 MM COCR HEAD & POLYETHLENE LINER receive FDA 510(k) clearance?

22 MM COCR HEAD & POLYETHLENE LINER received FDA 510(k) clearance on 1996-05-02, under 510(k) number K960180.

Who is the listed applicant for 22 MM COCR HEAD & POLYETHLENE LINER?

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

What is the FDA product code for 22 MM COCR HEAD & POLYETHLENE LINER?

The FDA product code for 22 MM COCR HEAD & POLYETHLENE LINER is LPH.

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Other records listing Stelkast Company as applicant

K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM K122773CROSS-OVER ACETABULAR SHELL & LINER K094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM K081458PROVEN STEM EXTENDER K063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT K051976PROVEN REVISION MODULAR TIBIAL TRAY

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Related Devices (Code: LPH)

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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.