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FDA 510(k)

M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.

K-Number: K890054 · 1989-02-08

ApplicantProtek, Inc.
Decision Date1989-02-08
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K890054. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.?

M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Protek, Inc.. The 510(k) number is K890054.

When did M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. receive FDA 510(k) clearance?

M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. received FDA 510(k) clearance on 1989-02-08, under 510(k) number K890054.

Who is the listed applicant for M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.?

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 M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.?

The FDA product code for M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. is JDI.

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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 SURK883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHK884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICK884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

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Related Devices (Code: JDI)

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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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