Sulzer Orthopedics, Inc.
Austin, TX, US
Sulzer Orthopedics, Inc. appears in FDA device records in Austin, TX. FDA records list 45 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 45
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 45 510(k) clearances for Sulzer Orthopedics, Inc. between 1997 and 2002. The busiest year on record is 1997, with 13. The most recent is 2002, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 13 |
| 1998 | 5 |
| 1999 | 7 |
| 2000 | 7 |
| 2001 | 10 |
| 2002 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022985 | ASCENDENT ACETABULAR SYSTEM | LZO | Substantially Equivalent | |
| K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE | JWH | Substantially Equivalent | |
| K020713 | MS-30 LATERAL FEMORAL STEM | LZO | Substantially Equivalent | |
| K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS | LZO | Substantially Equivalent | |
| K013031 | MOST OPTIONS SYSTEM | KRO | Substantially Equivalent | |
| K012739 | CONVERGE ACETABULAR SYSTEM | LPH | Substantially Equivalent | |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | JDI | Substantially Equivalent | |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | HSX | Substantially Equivalent | |
| K010839 | CLS VARUS STEM/CLS 135 STEM | LZO | Substantially Equivalent | |
| K003758 | ALLOFIT ACETABULAR SYSTEM | KWA | Substantially Equivalent | |
| K003801 | ANATOMICAL PRESS-FIT HUMERAL STEM | KWS | Substantially Equivalent | |
| K003832 | SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM | KWS | Substantially Equivalent | |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | HSH | Substantially Equivalent | |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | LWJ | Substantially Equivalent | |
| K002356 | NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS | KRR | Substantially Equivalent | |
| K002335 | NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA | JWH | Substantially Equivalent | |
| K001536 | INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS | KWA | Substantially Equivalent | |
| K001320 | SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM | LPH | Substantially Equivalent | |
| K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM | JDI | Substantially Equivalent | |
| K993259 | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS | LPH | Substantially Equivalent | |
| K993043 | MS-30 FEMORAL STEM | LZO | Substantially Equivalent | |
| K974728 | INTER-OP METASUL ACETABULAR SYSTEM | KWA | Substantially Equivalent | |
| K991143 | MAGNA-ROM 21 KNEE SYSTEEM | JWH | Substantially Equivalent | |
| K990136 | ANATOMICA GLENOID COMPONENT | KWS | Substantially Equivalent | |
| K990137 | ANATOMICA HUMERAL STEM/HEAD COMPONENTS | KWS | Substantially Equivalent | |
| K983509 | INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT | LPH | Substantially Equivalent | |
| K983592 | SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS | HWC | Substantially Equivalent | |
| K983733 | SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS | JWH | Substantially Equivalent | |
| K983153 | NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS | JWH | Substantially Equivalent | |
| K982903 | SULZER ORTHOPEDICS FLUTED STEMS | JWH | Substantially Equivalent | |
| K981211 | APR -T REVISION HIP STEM | LPH | Substantially Equivalent | |
| K973837 | CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL | LZO | Substantially Equivalent for Some Indications | |
| K973681 | NATURAL-HIP COCR OFFSET STEM | LZO | Substantially Equivalent | |
| K973675 | NATURAL-HIP POROUS STEM WITH OFFSET | LPH | Substantially Equivalent | |
| K973412 | NATURAL-KNEE II CONSTRAINED KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | |
| K973087 | MOST HEX INTRAMEDULLARY (I/M) STEM | LZO | Substantially Equivalent | |
| K973124 | APR POROUS HA HIP SYSTEM | LPH | Substantially Equivalent for Some Indications | |
| K972637 | PRECEDENT REVISION HIP SYSTEM | LZO | Substantially Equivalent | |
| K972501 | APOLLO REVISION/CONSTRAINED KNEE SYSTEM | JWH | Substantially Equivalent | |
| K971523 | DISTALLY FIXED HIP STEM | MEH | Substantially Equivalent for Some Indications | |
| K972393 | INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) | LPH | Substantially Equivalent | |
| K971715 | SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS | KWS | Substantially Equivalent | |
| K971770 | APOLLO KNEE FEMORAL SPACERS | JWH | Substantially Equivalent | |
| K970706 | INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES | LPH | Substantially Equivalent | |
| K970705 | INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES | LPH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain