The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Pro Osteon Implant 500r Resorbable Bone Graft Substitute Model Numbers 5rg05, 5rg10, 5rg15, 5g15l, 5rg20, 5rg30, 5rg30l.
| Device ID | K980817 |
| 510k Number | K980817 |
| Device Name: | PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | David P Balding |
| Correspondent | David P Balding INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-09-25 |
| Summary: | summary |