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FDA 510(k)

ARC-2F ACETABULAR CUP

K-Number: K893785 · 1989-08-09

ApplicantProtek, Inc.
Decision Date1989-08-09
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ARC-2F ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1989-08-09 under 510(k) number K893785. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ARC-2F ACETABULAR CUP?

ARC-2F ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1989-08-09. The listed applicant is Protek, Inc.. The 510(k) number is K893785.

When did ARC-2F ACETABULAR CUP receive FDA 510(k) clearance?

ARC-2F ACETABULAR CUP received FDA 510(k) clearance on 1989-08-09, under 510(k) number K893785.

Who is the listed applicant for ARC-2F ACETABULAR CUP?

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 ARC-2F ACETABULAR CUP?

The FDA product code for ARC-2F ACETABULAR CUP 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.

K893959P.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.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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