APR METASUL ACETABULAR INSERT— 510(k) K993569

Name: FDA 510(k) clearance K993569
Creator: U.S. Food and Drug Administration
Published: 1999-12-01

Substantially Equivalent

Sulzermedica

FDA 510(k) clearance K993569 for APR METASUL ACETABULAR INSERT, Substantially Equivalent on 1999-12-01. Applicant: Sulzermedica. Device class: 3.

Clearance details

Applicant: Sulzermedica
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 1999-10-21
Decision date: 1999-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWA

view all

K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
K121544 — DYNASTY BIOFOAM SHELL2012-07-30
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

More clearances from Sulzermedica

view all

K002324 — MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA2000-08-24
K993667 — SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS2000-01-28
K990503 — SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS1999-12-09
K992832 — SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS1999-11-19

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.