The following data is part of a premarket notification filed by Sirakoss Ltd. with the FDA for Osteo3 Zp Putty.
| Device ID | K193075 |
| 510k Number | K193075 |
| Device Name: | Osteo3 ZP Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Sirakoss Ltd. Level 4, Polwarth Building, Foresterhill Aberdeen, GB Ab25 2zd |
| Contact | Jordan Conway |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2020-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350086550726 | K193075 | 000 |
| 07350086550719 | K193075 | 000 |
| 07350086550702 | K193075 | 000 |