Ascendent Acetabular System

• • Terminated Z-0809-04 FDA Unclassified (pre-2012) ·initiated 30 Sep 2003

  Compalints of acetabular shell disassociating with the bone.

510(k) Number

K022985 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Sulzer Orthopedics Converge Acetabular System

  Class II

  FDA 510(k) K012961 Active Cleared 18 Oct 2001

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

See all devices from Sulzer Orthopedics, Inc. →