PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
FDA premarket approval P860005/S011 · decided 1999-05-25
Approval details
- PMA number
- P860005
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Interpore Intl.
- Date received
- 1999-04-22
- Decision date
- 1999-05-25
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for updated labeling that reflects the results of the completed post-market approval study.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ULTRACON ULTRAFILTRATOR (K981253) | Interpore Intl. | 1998-12-11 |
| PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L (K980817) | Interpore Intl. | 1998-09-25 |
| INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (K972842) | Interpore Intl. | 1997-10-30 |
| ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (K971036) | Interpore Intl. | 1997-06-03 |
| IMZ MEMBRANE TACK SYSTEM (K960945) | Interpore Intl. | 1996-05-24 |
| INTERPORE THREADED IMPLANT (K960371) | Interpore Intl. | 1996-03-08 |
| INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT (K955492) | Interpore Intl. | 1996-01-30 |
| IMZ BONE TACK SYSTEM (K952167) | Interpore Intl. | 1995-11-21 |