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FDA 510(k)

RESUBMITTED CLW ACETABULAR CUP W/SULMESH

K-Number: K883794 · 1989-05-26

ApplicantProtek, Inc.
Decision Date1989-05-26
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED CLW ACETABULAR CUP W/SULMESH is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K883794. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUBMITTED CLW ACETABULAR CUP W/SULMESH?

RESUBMITTED CLW ACETABULAR CUP W/SULMESH is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is Protek, Inc.. The 510(k) number is K883794.

When did RESUBMITTED CLW ACETABULAR CUP W/SULMESH receive FDA 510(k) clearance?

RESUBMITTED CLW ACETABULAR CUP W/SULMESH received FDA 510(k) clearance on 1989-05-26, under 510(k) number K883794.

Who is the listed applicant for RESUBMITTED CLW ACETABULAR CUP W/SULMESH?

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

What is the FDA product code for RESUBMITTED CLW ACETABULAR CUP W/SULMESH?

The FDA product code for RESUBMITTED CLW ACETABULAR CUP W/SULMESH is LWJ.

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Other records listing Protek, 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.

K893785ARC-2F ACETABULAR CUPK893959P.S.A. FEMORAL HIP PROSTHESISK892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURK884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICK884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.K884789NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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