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FDA 510(k)

SAMUELSON ACETABULAR CUP

K-Number: K872985 · 1987-10-01

ApplicantProtek, Inc.
Decision Date1987-10-01
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAMUELSON 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 1987-10-01 under 510(k) number K872985. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMUELSON ACETABULAR CUP?

SAMUELSON ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1987-10-01. The listed applicant is Protek, Inc.. The 510(k) number is K872985.

When did SAMUELSON ACETABULAR CUP receive FDA 510(k) clearance?

SAMUELSON ACETABULAR CUP received FDA 510(k) clearance on 1987-10-01, under 510(k) number K872985.

Who is the listed applicant for SAMUELSON 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 SAMUELSON ACETABULAR CUP?

The FDA product code for SAMUELSON ACETABULAR CUP is KWA.

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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.

View all 25 devices →

Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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