The following data is part of a premarket notification filed by Osseon Therapeutics, Inc. with the FDA for Osseoflex Sb Inflatable Bone Tamp.
| Device ID | K122533 |
| 510k Number | K122533 |
| Device Name: | OSSEOFLEX SB INFLATABLE BONE TAMP |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | OSSEON THERAPEUTICS, INC. 2330 CIRCADIAN WAY Santa Rosa, CA 95407 |
| Contact | Keith Burger |
| Correspondent | Keith Burger OSSEON THERAPEUTICS, INC. 2330 CIRCADIAN WAY Santa Rosa, CA 95407 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2012-10-23 |
| Summary: | summary |