FDA 510(k) Applications Submitted by SULZER ORTHOPEDICS, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K010839 |
03/21/2001 |
CLS VARUS STEM/CLS 135 STEM |
SULZER ORTHOPEDICS, INC. |
K011954 |
06/22/2001 |
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE |
SULZER ORTHOPEDICS, INC. |
K983153 |
09/09/1998 |
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS |
SULZER ORTHOPEDICS, INC. |
K020713 |
03/05/2002 |
MS-30 LATERAL FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
K001078 |
04/04/2000 |
SULZER ORTHOPEDICS MS-30 FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
K001320 |
04/26/2000 |
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM |
SULZER ORTHOPEDICS, INC. |
K021578 |
05/14/2002 |
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE |
SULZER ORTHOPEDICS, INC. |
K022985 |
09/09/2002 |
ASCENDENT ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
K013031 |
09/10/2001 |
MOST OPTIONS SYSTEM |
SULZER ORTHOPEDICS, INC. |
K971715 |
05/09/1997 |
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS |
SULZER ORTHOPEDICS, INC. |
K971770 |
05/13/1997 |
APOLLO KNEE FEMORAL SPACERS |
SULZER ORTHOPEDICS, INC. |
K972393 |
06/26/1997 |
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) |
SULZER ORTHOPEDICS, INC. |
K972501 |
07/03/1997 |
APOLLO REVISION/CONSTRAINED KNEE SYSTEM |
SULZER ORTHOPEDICS, INC. |
K972637 |
07/15/1997 |
PRECEDENT REVISION HIP SYSTEM |
SULZER ORTHOPEDICS, INC. |
K973412 |
09/09/1997 |
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM |
SULZER ORTHOPEDICS, INC. |
K973124 |
08/20/1997 |
APR POROUS HA HIP SYSTEM |
SULZER ORTHOPEDICS, INC. |
K002335 |
08/01/2000 |
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA |
SULZER ORTHOPEDICS, INC. |
K990137 |
01/14/1999 |
ANATOMICA HUMERAL STEM/HEAD COMPONENTS |
SULZER ORTHOPEDICS, INC. |
K990136 |
01/14/1999 |
ANATOMICA GLENOID COMPONENT |
SULZER ORTHOPEDICS, INC. |
K001536 |
05/17/2000 |
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS |
SULZER ORTHOPEDICS, INC. |
K002356 |
08/02/2000 |
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS |
SULZER ORTHOPEDICS, INC. |
K012739 |
08/16/2001 |
CONVERGE ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
K973087 |
08/18/1997 |
MOST HEX INTRAMEDULLARY (I/M) STEM |
SULZER ORTHOPEDICS, INC. |
K982903 |
08/18/1998 |
SULZER ORTHOPEDICS FLUTED STEMS |
SULZER ORTHOPEDICS, INC. |
K002575 |
08/18/2000 |
INTER-OP DURASUL ACETABULAR INSERTS (4MM) |
SULZER ORTHOPEDICS, INC. |
K012961 |
09/04/2001 |
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
K993043 |
09/10/1999 |
MS-30 FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
K973675 |
09/26/1997 |
NATURAL-HIP POROUS STEM WITH OFFSET |
SULZER ORTHOPEDICS, INC. |
K973681 |
09/26/1997 |
NATURAL-HIP COCR OFFSET STEM |
SULZER ORTHOPEDICS, INC. |
K993259 |
09/29/1999 |
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS |
SULZER ORTHOPEDICS, INC. |
K983592 |
10/13/1998 |
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS |
SULZER ORTHOPEDICS, INC. |
K003269 |
10/18/2000 |
UNICONDYLAR INTERPOSITIONAL SPACER |
SULZER ORTHOPEDICS, INC. |
K983733 |
10/22/1998 |
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS |
SULZER ORTHOPEDICS, INC. |
K013935 |
11/28/2001 |
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS |
SULZER ORTHOPEDICS, INC. |
K003758 |
12/06/2000 |
ALLOFIT ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
K003801 |
12/08/2000 |
ANATOMICAL PRESS-FIT HUMERAL STEM |
SULZER ORTHOPEDICS, INC. |
K003832 |
12/11/2000 |
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM |
SULZER ORTHOPEDICS, INC. |
K974728 |
12/18/1997 |
INTER-OP METASUL ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
K971523 |
04/28/1997 |
DISTALLY FIXED HIP STEM |
SULZER ORTHOPEDICS, INC. |
K973837 |
10/08/1997 |
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL |
SULZER ORTHOPEDICS, INC. |
K970706 |
02/26/1997 |
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES |
SULZER ORTHOPEDICS, INC. |
K970705 |
02/26/1997 |
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES |
SULZER ORTHOPEDICS, INC. |
K991143 |
04/05/1999 |
MAGNA-ROM 21 KNEE SYSTEEM |
SULZER ORTHOPEDICS, INC. |
K981211 |
04/02/1998 |
APR -T REVISION HIP STEM |
SULZER ORTHOPEDICS, INC. |
K983509 |
10/07/1998 |
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT |
SULZER ORTHOPEDICS, INC. |
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