The following data is part of a premarket notification filed by Allosource, Inc. with the FDA for Allofuse Plus.
| Device ID | K103036 |
| 510k Number | K103036 |
| Device Name: | ALLOFUSE PLUS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ALLOSOURCE, INC. 6278 S. TROY CIRCLE Centennial, CO 80111 |
| Contact | Pamela Vetter |
| Correspondent | Pamela Vetter ALLOSOURCE, INC. 6278 S. TROY CIRCLE Centennial, CO 80111 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-13 |
| Decision Date | 2011-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517971586 | K103036 | 000 |
| 00887517970442 | K103036 | 000 |
| 00887517970459 | K103036 | 000 |
| 00887517970466 | K103036 | 000 |
| 00887517970480 | K103036 | 000 |
| 00887517971500 | K103036 | 000 |
| 00887517971524 | K103036 | 000 |
| 00887517971531 | K103036 | 000 |
| 00887517971548 | K103036 | 000 |
| 00887517971555 | K103036 | 000 |
| 00887517971562 | K103036 | 000 |
| 00887517971579 | K103036 | 000 |
| 00887517970435 | K103036 | 000 |