Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI

K-Number: K884789 · 1989-02-08

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

Device Summary

NEW JERSEY FEMORAL HIP PROSTHESIS 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 K884789. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI?

NEW JERSEY FEMORAL HIP PROSTHESIS 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 K884789.

When did NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI receive FDA 510(k) clearance?

NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI received FDA 510(k) clearance on 1989-02-08, under 510(k) number K884789.

Who is the listed applicant for NEW JERSEY FEMORAL HIP PROSTHESIS 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 NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI?

The FDA product code for NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI is KWL.

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 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: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus 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.

↑