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FDA 510(k)

PM CEMENTLESS SCREW-IN ACETABULAR CUP

K-Number: K850773 · 1985-05-02

ApplicantAdvanced Biosearch Assn.
Decision Date1985-05-02
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PM CEMENTLESS SCREW-IN ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1985-05-02 under 510(k) number K850773. 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 PM CEMENTLESS SCREW-IN ACETABULAR CUP?

PM CEMENTLESS SCREW-IN ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1985-05-02. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K850773.

When did PM CEMENTLESS SCREW-IN ACETABULAR CUP receive FDA 510(k) clearance?

PM CEMENTLESS SCREW-IN ACETABULAR CUP received FDA 510(k) clearance on 1985-05-02, under 510(k) number K850773.

Who is the listed applicant for PM CEMENTLESS SCREW-IN ACETABULAR CUP?

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

What is the FDA product code for PM CEMENTLESS SCREW-IN ACETABULAR CUP?

The FDA product code for PM CEMENTLESS SCREW-IN ACETABULAR CUP is KWA.

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Other records listing Advanced Biosearch Assn. 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.

K905514AUTOGENESIS(TM) AUTOMATORK883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMK855030CHAMPY BONE PLATES & BONE SCREWSK855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PK853916P.M. HIP-FEMORAL PROSTHESIS

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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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