Medical Device Manufacturer · US , Austin , TX

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

45 submissions · 41 cleared · Since 1997
45
Total
41
Cleared
0
Denied
45 devices
26-45 of 45
Cleared Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
K983509 · LPH
Orthopedic · 119d
Cleared Jan 28, 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · HWC
Orthopedic · 107d
Cleared Dec 18, 1998
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
K983733 · JWH
Orthopedic · 57d
Cleared Dec 04, 1998
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · JWH
Orthopedic · 86d
Cleared Oct 21, 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · JWH
Orthopedic · 64d
Cleared May 22, 1998
APR -T REVISION HIP STEM
K981211 · LPH
Orthopedic · 50d
Cleared Jan 06, 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
K973837 · LZO
Orthopedic · 90d
Cleared Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
K973675 · LPH
Orthopedic · 84d
Cleared Dec 19, 1997
NATURAL-HIP COCR OFFSET STEM
K973681 · LZO
Orthopedic · 84d
Cleared Dec 08, 1997
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
K973412 · JWH
Orthopedic · 90d
Cleared Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087 · LZO
Orthopedic · 88d
Cleared Nov 03, 1997
APR POROUS HA HIP SYSTEM
K973124 · LPH
Orthopedic · 75d
Cleared Oct 01, 1997
DISTALLY FIXED HIP STEM
K971523 · MEH
Orthopedic · 156d
Cleared Oct 01, 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501 · JWH
Orthopedic · 90d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · LZO
Orthopedic · 78d
Cleared Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · LPH
Orthopedic · 85d
Cleared Aug 07, 1997
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
K971715 · KWS
Orthopedic · 90d
Cleared Jul 31, 1997
APOLLO KNEE FEMORAL SPACERS
K971770 · JWH
Orthopedic · 79d
Cleared May 22, 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
K970705 · LPH
Orthopedic · 85d
Cleared May 22, 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
K970706 · LPH
Orthopedic · 85d
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