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.
Approval to replace static compression testing with ultimate compression testing during the manufacturing process following depyrogenation.
| Device | PRO OSTEON 500 BONE GRAFT SUBSTITUTE |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | INTERPORE INTL. |
| Date Received | 2001-12-04 |
| Decision Date | 2002-05-31 |
| PMA | P860005 |
| Supplement | S012 |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTERPORE INTL. 181 Technology Dr. irvine, CA 92618-2402 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860005 | Original Filing | |
| S012 | 2001-12-04 | Normal 180 Day Track |
| S011 | 1999-04-22 | Normal 180 Day Track |
| S010 | 1997-11-18 | Normal 180 Day Track |
| S009 | 1997-10-27 | Normal 180 Day Track |
| S008 | 1997-08-28 | Normal 180 Day Track |
| S007 | 1997-05-15 | Normal 180 Day Track |
| S006 | ||
| S005 | 1996-04-29 | Normal 180 Day Track |
| S004 | 1994-02-22 | Normal 180 Day Track |
| S003 | 1993-10-15 | Normal 180 Day Track |
| S002 | 1993-03-23 | Normal 180 Day Track |
| S001 | 1993-02-08 | Normal 180 Day Track |