The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Fm-02 Bone Graft Substitute.
| Device ID | K102545 |
| 510k Number | K102545 |
| Device Name: | FM-02 BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2010-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327124231 | K102545 | 000 |
| 07613327124224 | K102545 | 000 |
| 07613327124217 | K102545 | 000 |
| 07613327124200 | K102545 | 000 |
| 00808232000702 | K102545 | 000 |
| 00808232000696 | K102545 | 000 |
| 00808232000689 | K102545 | 000 |
| 00808232000672 | K102545 | 000 |