PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
FDA premarket approval P860005/S009 · decided 1998-04-28
Approval details
- PMA number
- P860005
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Interpore Intl.
- Date received
- 1997-10-27
- Decision date
- 1998-04-28
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for several labeling changes as identified and agreed upon in an April 17, 1998 facsimile of the labeling. The device name will also be modified and will be marketed under the trade name "Pro Osteon(R) Implant 500 Porous Hydroxyapatite Bone Graft Substitute Blocks and Granules." The device is indicated for the repair of metaphyseal fracture defects and long bone cyst and tumor defects. For metaphyseal fracture defects, the device is indicated for treatment which occurs within one month
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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 |