The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Intergro Dbm.
| Device ID | K031399 |
| 510k Number | K031399 |
| Device Name: | INTERGRO DBM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Mark Loar |
| Correspondent | Mark Loar 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 | 2003-05-05 |
| Decision Date | 2005-02-18 |
| Summary: | summary |