The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Pro Osteon 200r Resorbable Bone Graft Substitute, Models 2rg051, 2rg101, 2rg151, 2rg201, 2rg301, 2rg050, 2rg100, 2rg150,.
| Device ID | K000515 |
| 510k Number | K000515 |
| Device Name: | PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Prosie Rey-fessler |
| Correspondent | Prosie Rey-fessler 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 | 2000-02-16 |
| Decision Date | 2000-09-15 |
| Summary: | summary |