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FDA 510(k)

P.S.A. FEMORAL HIP PROSTHESIS

K-Number: K893959 · 1989-07-25

ApplicantProtek, Inc.
Decision Date1989-07-25
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.S.A. FEMORAL HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893959. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.S.A. FEMORAL HIP PROSTHESIS?

P.S.A. FEMORAL HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Protek, Inc.. The 510(k) number is K893959.

When did P.S.A. FEMORAL HIP PROSTHESIS receive FDA 510(k) clearance?

P.S.A. FEMORAL HIP PROSTHESIS received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893959.

Who is the listed applicant for P.S.A. FEMORAL HIP PROSTHESIS?

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 P.S.A. FEMORAL HIP PROSTHESIS?

The FDA product code for P.S.A. FEMORAL HIP PROSTHESIS is KWY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CUPK892059FEMORAL 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

View all 25 devices →

Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbH

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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