The following data is part of a premarket notification filed by Biomet Spine with the FDA for Intergro Dbm.
| Device ID | K082793 |
| 510k Number | K082793 |
| Device Name: | INTERGRO DBM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMET SPINE 181 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Kathleen Ideo |
| Correspondent | Kathleen Ideo BIOMET SPINE 181 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | MQV |
| Subsequent Product Code | GXP |
| Subsequent Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2009-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304706408 | K082793 | 000 |
| 00888480585138 | K082793 | 000 |
| 00888480585145 | K082793 | 000 |
| 00888480585169 | K082793 | 000 |
| 00888480585213 | K082793 | 000 |
| 00888480585220 | K082793 | 000 |
| 00888480585251 | K082793 | 000 |
| 00880304683907 | K082793 | 000 |
| 00880304684836 | K082793 | 000 |
| 00880304684850 | K082793 | 000 |
| 00880304684867 | K082793 | 000 |
| 00880304684874 | K082793 | 000 |
| 00880304684881 | K082793 | 000 |
| 00880304686816 | K082793 | 000 |
| 00880304686830 | K082793 | 000 |
| 00888480585121 | K082793 | 000 |