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 for a change to the name of the product from "bone void filler" to "bone graft substitute. " the device, as modified in designation, will be marketed under the trade name "pro osteon implant 500 porous coralline hydroxyapatite bone graft substitute blocks and granules," and is indicated for the same indications approved in the original pma and in p860006/s002.
| Device | PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | INTERPORE INTL. |
| Date Received | 1997-11-18 |
| Decision Date | 1998-01-08 |
| PMA | P860005 |
| Supplement | S010 |
| Product Code | MBS |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |