The following data is part of a premarket notification filed by Spinecraft, Inc. with the FDA for Osteopore Tcp.
| Device ID | K062496 |
| 510k Number | K062496 |
| Device Name: | OSTEOPORE TCP |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SPINECRAFT, INC. 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154 |
| Contact | Ami Akallal-assad |
| Correspondent | Ami Akallal-assad SPINECRAFT, INC. 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2006-10-19 |
| Summary: | summary |