The following data is part of a premarket notification filed by Progentix Orthobiology B.v. with the FDA for Attrax Putty.
| Device ID | K151584 |
| 510k Number | K151584 |
| Device Name: | AttraX Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PROGENTIX ORTHOBIOLOGY B.V. PROF. BRONKHORSTLAAN 10 BLDG. 48 Bilthoven, NL 3723 Mb |
| Contact | Yvonne P. Bovell |
| Correspondent | Yvonne P. Bovell PROGENTIX ORTHOBIOLOGY B.V. PROF. BRONKHORSTLAAN 10 BLDG. 48 Bilthoven, NL 3723 Mb |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-11 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517241566 | K151584 | 000 |
| 00887517241559 | K151584 | 000 |
| 00887517241542 | K151584 | 000 |
| 00887517241535 | K151584 | 000 |
| 00887517241528 | K151584 | 000 |