The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Pro Osteon 200r With Calcium Sulfate, Models 2rcs038, 2rcs050, 2rcs075, 2rcs10, 2rcs15, 2rcs20, 2rcs225, 2rcs30.
| Device ID | K004003 |
| 510k Number | K004003 |
| Device Name: | PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 |
| 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 | 2000-12-25 |
| Decision Date | 2001-07-19 |