ASCENT KNEE SYSTEM— 510(k) K994326

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K994326 for ASCENT KNEE SYSTEM, Substantially Equivalent on 2000-01-07. Applicant: Biomet Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1999-12-22
Decision date: 2000-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWH

K191966 — NewPrim System2020-02-13
K190136 — Fusion Silastic System2019-10-21
K173491 — RTS Lesser MTP Implant System2018-02-23
K153609 — RTS Flexible 1 MPJ Implant w/Grommets2016-09-08
K102601 — ORTHOFLEX ROD2011-01-14

More clearances from Biomet Manufacturing, Inc.

K130390 — COMPREHENSIVE CONVERTIBLE GLENOID2013-10-09
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113121 — COMPREHENSIVE REVERSE SHOULDER2011-12-16
K080685 — HIPLOC COMPRESSION HIP SCREW2008-08-15
K080088 — BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS2008-06-11

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