The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Pro Osteon Implant 500r Resorbable Bone Graft Substitute.
| Device ID | K990131 |
| 510k Number | K990131 |
| Device Name: | PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn M Rodarti |
| Correspondent | Lynn M Rodarti INTERPORE CROSS 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 | 1999-01-14 |
| Decision Date | 1999-03-02 |
| Summary: | summary |