Intermedics Orthopedics
Mchenry, IL, US
Intermedics Orthopedics appears in FDA device records in Mchenry, IL. FDA records list 108 510(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
- 108
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 108FDA records hold 108 510(k) clearances for Intermedics Orthopedics between 1982 and 1997. The busiest year on record is 1996, with 26. The most recent is 1997, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 10 |
| 1983 | 3 |
| 1985 | 4 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 2 |
| 1989 | 7 |
| 1990 | 2 |
| 1991 | 11 |
| 1992 | 2 |
| 1993 | 6 |
| 1994 | 11 |
| 1995 | 14 |
| 1996 | 26 |
| 1997 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | LPH | Substantially Equivalent | |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | JWH | Substantially Equivalent | |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | LZO | Substantially Equivalent | |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | KWT | Substantially Equivalent | |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | LZO | Substantially Equivalent | |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | JDI | Substantially Equivalent | |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | KRR | Substantially Equivalent | |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | LPH | Substantially Equivalent | |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | LWJ | Substantially Equivalent | |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | KWT | Substantially Equivalent | |
| K962289 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | HSD | Substantially Equivalent | |
| K962224 | SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS | KWS | Substantially Equivalent | |
| K962101 | ZWEYMUELLER SL FEMORAL HIP STEM | LZO | Substantially Equivalent | |
| K962244 | SELECT SHOULDER PEGGED ALL-POLY GLENOID | KWT | Substantially Equivalent for Some Indications | |
| K962238 | SELECT SHOULDER KEELED ALL-POLY GLENOIDS | KWT | Substantially Equivalent for Some Indications | |
| K961921 | APR OVERSIZED HIP STEM | LZO | Substantially Equivalent | |
| K960588 | WAGNER REVISION STEM | LZO | Substantially Equivalent | |
| K961727 | NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM | LZO | Substantially Equivalent | |
| K961799 | NATURAL HIP SYSTEM - DRG HIP STEM | JDI | Substantially Equivalent | |
| K960258 | NATURAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K961589 | APR FULLY TEXTURED HIP STEM | LZO | Substantially Equivalent | |
| K960025 | PROTEK LOW PROFILE ACETABULAR CUP | JDI | Substantially Equivalent | |
| K953690 | CLS STEM (MODIFICATION) | LZO | Substantially Equivalent | |
| K960678 | BURCH/SCHNEIDER REINFORCEMENT CAGE | JDI | Substantially Equivalent | |
| K934695 | NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA | JWH | Substantially Equivalent | |
| K954800 | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) | MEH | Substantially Equivalent for Some Indications | |
| K960535 | APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA | JWH | Substantially Equivalent | |
| K960626 | MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) | JDI | Substantially Equivalent | |
| K955739 | MODULAR ACETABULAR SHELL II | LPH | Substantially Equivalent | |
| K955778 | NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM | HRY | Substantially Equivalent for Some Indications | |
| K954854 | INTERMOORE FRACTURE HIP STEM | LWJ | Substantially Equivalent | |
| K955033 | RIM FLARE ACETABULAR COMPONENT | LPH | Substantially Equivalent | |
| K935585 | APR ACETABULAR INSERTS IOI BIPOLAR | JDI | Substantially Equivalent | |
| K953689 | WAGNER REVISION STEM (MODIFICATION) | LZO | Substantially Equivalent | |
| K953688 | CLS ACETABULAR COMPONENT (MODIFICATION) | LZO | Substantially Equivalent | |
| K953578 | PROTEK ACETABULAR ROOF REINFORCEMENT RING | JDI | Substantially Equivalent | |
| K935523 | NATURAL-KNEE(R)/APOLLO(TM) KNEE | JWH | Substantially Equivalent | |
| K936159 | NATURAL-KNEE II SYSTEM | JWH | Substantially Equivalent for Some Indications | |
| K935802 | SELECT(R) SHOULDER ALL POLY GLENOID | KWS | Substantially Equivalent | |
| K950998 | MODUILAR UNIPOLAR | KXA | Substantially Equivalent | |
| K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK | JDQ | Substantially Equivalent for Some Indications | |
| K944529 | CABLE-EASE PLATE AND CABLE SYSTEM | JDQ | Substantially Equivalent for Some Indications | |
| K945516 | NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM | LZO | Substantially Equivalent for Some Indications | |
| K934381 | APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT | JWH | Substantially Equivalent for Some Indications | |
| K935789 | POSTERIOR STABILIZED APOLLO KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | |
| K933229 | APOLLO KNEE FEMORAL COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K944209 | APR II NON POROUS HIP STEM | LZO | Substantially Equivalent for Some Indications | |
| K941617 | APR ACETABULAR INSERT | JDI | Substantially Equivalent | |
| K942406 | OPTION SHELL | JDI | Substantially Equivalent | |
| K942330 | APR II FEMORAL COMPONENT (VARIOUS) | LZO | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFABlade, Saw, General & Plastic Surgery, Surgical
- JOLCatheter And Tip, Suction
- JDQCerclage, Fixation
- FYEDress, Surgical
- HTPFile
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis
- HRSPlate, Fixation, Bone
- KXAProsthesis, Hip, Femoral, Resurfacing
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal
- 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
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- 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