Medical Device Manufacturer · US , Austin , TX

Centerpulse Orthopedics, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2003

Recent clearances: ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED, EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED, DURASUL BIPOLAR

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Centerpulse Orthopedics, Inc. Orthopedic ✕

10 devices

1-10 of 10

Cleared Oct 18, 2004

ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED

Orthopedic · 304d

Cleared Sep 15, 2004

EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED

Orthopedic · 301d

Cleared Aug 27, 2004

DURASUL BIPOLAR

Orthopedic · 137d

Cleared Mar 05, 2004

NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM

Orthopedic · 88d

Cleared Dec 17, 2003

MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM

Orthopedic · 26d

Cleared Oct 24, 2003

CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP

Orthopedic · 86d

Cleared Oct 03, 2003

EPSILON DURASUL CONSTRAINED ACETABULAR LINER

Orthopedic · 193d

Cleared Sep 22, 2003

WAGNER CONE PROSTHESIS

Orthopedic · 52d

Cleared Jul 14, 2003

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE

Orthopedic · 90d

Cleared Mar 06, 2003

ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Orthopedic · 30d