Medical Device Manufacturer · US , Austin , TX

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

45 submissions · 41 cleared · Since 1997

Recent clearances: ASCENDENT ACETABULAR SYSTEM, NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE, MS-30 LATERAL FEMORAL STEM

45
Total
41
Cleared
0
Denied

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

45 devices
1-12 of 45
Cleared Dec 05, 2002
ASCENDENT ACETABULAR SYSTEM
K022985 · LZO
Orthopedic · 87d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · JWH
Orthopedic · 87d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713 · LZO
Orthopedic · 70d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · LZO
Orthopedic · 15d
Cleared Dec 07, 2001
MOST OPTIONS SYSTEM
K013031 · KRO
Orthopedic · 88d
Cleared Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739 · LPH
Orthopedic · 90d
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · JDI
Orthopedic · 44d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · HSX
Orthopedic · 89d
Cleared Apr 18, 2001
CLS VARUS STEM/CLS 135 STEM
K010839 · LZO
Orthopedic · 28d
Cleared Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758 · KWA
Orthopedic · 91d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · KWS
Orthopedic · 82d
Cleared Jan 04, 2001
UNICONDYLAR INTERPOSITIONAL SPACER
K003269 · HSH
Orthopedic · 78d

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