This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | OSTEO CERAMIC HIP |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | Smith & Nephew, Inc. |
| Date Received | 1984-12-13 |
| Decision Date | 1985-03-06 |
| PMA | P810048 |
| Supplement | S006 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Smith & Nephew, Inc. 1450 Brooks Rd. memphis, TN 38116 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810048 | Original Filing | |
| S012 | 1986-11-28 | Normal 180 Day Track |
| S011 | 1986-10-30 | Normal 180 Day Track |
| S010 | 1986-05-01 | Normal 180 Day Track |
| S009 | 1985-12-26 | Special (immediate Track) |
| S008 | 1985-02-26 | Normal 180 Day Track |
| S007 | 1985-02-19 | Normal 180 Day Track |
| S006 | 1984-12-13 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 1983-07-26 | Normal 180 Day Track |
| S002 | ||
| S001 | 1982-12-21 | Normal 180 Day Track |