Company ยท US
Intermedics Orthopedics
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1997. Name variants (Inc, Corp, punctuation) are merged.
108510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 19 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 17 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 5 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 5 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 4 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 3 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 |
| JDQ | Cerclage, Fixation | 2 |
| FYE | Dress, Surgical | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 |
| HTP | File | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 1997 | K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI Intermedics Orthopedics | LPH |
| Apr 30, 1997 | K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS Intermedics Orthopedics | JWH |
| Apr 8, 1997 | K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM Intermedics Orthopedics | LZO |
| Feb 27, 1997 | K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS Intermedics Orthopedics | KWT |
| Jan 27, 1997 | K964357 | NATURAL-HIP SYSTEM COCR STEM Intermedics Orthopedics | LZO |
| Jan 16, 1997 | K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA Intermedics Orthopedics | JDI |
| Oct 28, 1996 | K962190 | PATELLOFEMORAL JOINT PROSTHESIS Intermedics Orthopedics | KRR |
| Oct 15, 1996 | K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED Intermedics Orthopedics | LPH |
| Oct 1, 1996 | K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) Intermedics Orthopedics | LWJ |
| Sep 3, 1996 | K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT Intermedics Orthopedics | KWT |
| Aug 29, 1996 | K962289 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT Intermedics Orthopedics | HSD |
| Aug 28, 1996 | K962224 | SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS Intermedics Orthopedics | KWS |
| Aug 19, 1996 | K962101 | ZWEYMUELLER SL FEMORAL HIP STEM Intermedics Orthopedics | LZO |
| Aug 9, 1996 | K962244 | SELECT SHOULDER PEGGED ALL-POLY GLENOID Intermedics Orthopedics | KWT |
| Aug 9, 1996 | K962238 | SELECT SHOULDER KEELED ALL-POLY GLENOIDS Intermedics Orthopedics | KWT |
| Aug 5, 1996 | K961921 | APR OVERSIZED HIP STEM Intermedics Orthopedics | LZO |
| Aug 5, 1996 | K960588 | WAGNER REVISION STEM Intermedics Orthopedics | LZO |
| Jul 19, 1996 | K961727 | NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM Intermedics Orthopedics | LZO |
| Jul 15, 1996 | K961799 | NATURAL HIP SYSTEM - DRG HIP STEM Intermedics Orthopedics | JDI |
| Jul 12, 1996 | K960258 | NATURAL HIP SYSTEM Intermedics Orthopedics | JDI |
| Jul 9, 1996 | K961589 | APR FULLY TEXTURED HIP STEM Intermedics Orthopedics | LZO |
| Jun 7, 1996 | K960025 | PROTEK LOW PROFILE ACETABULAR CUP Intermedics Orthopedics | JDI |
| Jun 7, 1996 | K953690 | CLS STEM (MODIFICATION) Intermedics Orthopedics | LZO |
| May 3, 1996 | K960678 | BURCH/SCHNEIDER REINFORCEMENT CAGE Intermedics Orthopedics | JDI |
| May 2, 1996 | K934695 | NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA Intermedics Orthopedics | JWH |
| Apr 25, 1996 | K954800 | APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) Intermedics Orthopedics | MEH |
| Apr 23, 1996 | K960535 | APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA Intermedics Orthopedics | JWH |
| Apr 18, 1996 | K960626 | MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) Intermedics Orthopedics | JDI |
| Mar 27, 1996 | K955739 | MODULAR ACETABULAR SHELL II Intermedics Orthopedics | LPH |
| Mar 8, 1996 | K955778 | NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM Intermedics Orthopedics | HRY |
| Feb 15, 1996 | K954854 | INTERMOORE FRACTURE HIP STEM Intermedics Orthopedics | LWJ |
| Jan 31, 1996 | K955033 | RIM FLARE ACETABULAR COMPONENT Intermedics Orthopedics | LPH |
| Dec 13, 1995 | K935585 | APR ACETABULAR INSERTS IOI BIPOLAR Intermedics Orthopedics | JDI |
| Nov 29, 1995 | K953689 | WAGNER REVISION STEM (MODIFICATION) Intermedics Orthopedics | LZO |
| Nov 29, 1995 | K953688 | CLS ACETABULAR COMPONENT (MODIFICATION) Intermedics Orthopedics | LZO |
| Oct 30, 1995 | K953578 | PROTEK ACETABULAR ROOF REINFORCEMENT RING Intermedics Orthopedics | JDI |
| Jun 6, 1995 | K935523 | NATURAL-KNEE(R)/APOLLO(TM) KNEE Intermedics Orthopedics | JWH |
| May 22, 1995 | K936159 | NATURAL-KNEE II SYSTEM Intermedics Orthopedics | JWH |
| May 22, 1995 | K935802 | SELECT(R) SHOULDER ALL POLY GLENOID Intermedics Orthopedics | KWS |
| Apr 13, 1995 | K950998 | MODUILAR UNIPOLAR Intermedics Orthopedics | KXA |
| Mar 6, 1995 | K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK Intermedics Orthopedics | JDQ |
| Feb 17, 1995 | K944529 | CABLE-EASE PLATE AND CABLE SYSTEM Intermedics Orthopedics | JDQ |
| Feb 14, 1995 | K945516 | NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM Intermedics Orthopedics | LZO |
| Feb 8, 1995 | K934381 | APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT Intermedics Orthopedics | JWH |
| Feb 6, 1995 | K935789 | POSTERIOR STABILIZED APOLLO KNEE SYSTEM Intermedics Orthopedics | JWH |
| Jan 27, 1995 | K933229 | APOLLO KNEE FEMORAL COMPONENT Intermedics Orthopedics | JWH |
| Dec 9, 1994 | K944209 | APR II NON POROUS HIP STEM Intermedics Orthopedics | LZO |
| Oct 6, 1994 | K941617 | APR ACETABULAR INSERT Intermedics Orthopedics | JDI |
| Oct 5, 1994 | K942406 | OPTION SHELL Intermedics Orthopedics | JDI |
| Oct 4, 1994 | K942330 | APR II FEMORAL COMPONENT (VARIOUS) Intermedics Orthopedics | LZO |
Newest 50 of 108.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||