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FDA 510(k)

APR METASUL ACETABULAR INSERT

K-Number: K993569 · 1999-12-01

ApplicantSulzermedica
Decision Date1999-12-01
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APR METASUL ACETABULAR INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Sulzermedica. It received FDA 510(k) clearance on 1999-12-01 under 510(k) number K993569. 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 APR METASUL ACETABULAR INSERT?

APR METASUL ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 1999-12-01. The listed applicant is Sulzermedica. The 510(k) number is K993569.

When did APR METASUL ACETABULAR INSERT receive FDA 510(k) clearance?

APR METASUL ACETABULAR INSERT received FDA 510(k) clearance on 1999-12-01, under 510(k) number K993569.

Who is the listed applicant for APR METASUL ACETABULAR INSERT?

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

What is the FDA product code for APR METASUL ACETABULAR INSERT?

The FDA product code for APR METASUL ACETABULAR INSERT is KWA.

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 Sulzermedica 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.

K002324MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMAK993667SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESISK990503SULZER VASCUTEK GELSOFT VASCULAR PROSTHESISK992832SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS

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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