This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT |
| Classification Name | Bone Cement |
| Generic Name | Bone Cement |
| Applicant | HOWMEDICA CORP. |
| Date Received | 1971-10-07 |
| Decision Date | 1971-10-07 |
| PMA | N17004 |
| Supplement | S |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA CORP. 359 Veterans Blvd. rutherford, NJ 07070 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17004 | Original Filing | |
| S013 | 2000-12-01 | Real-time Process |
| S012 | 2000-05-23 | Real-time Process |
| S011 | 1998-02-03 | Normal 180 Day Track |
| S010 | 1997-10-17 | Real-time Process |
| S009 | 1997-06-16 | Normal 180 Day Track |
| S008 | 1996-11-18 | Real-time Process |
| S007 | ||
| S006 | 1994-09-26 | Normal 180 Day Track |
| S005 | 1994-02-22 | Normal 180 Day Track |
| S004 | 1993-05-21 | Normal 180 Day Track |
| S003 | 1991-10-08 | Normal 180 Day Track |
| S002 | 1990-04-30 | Normal 180 Day Track |
| S001 | 1981-03-03 |