The following data is part of a premarket notification filed by Osseon Llc with the FDA for Osseoflex Sb, 10g/4ml, Osseoflex Sb, 10g/2ml.
| Device ID | K141930 |
| 510k Number | K141930 |
| Device Name: | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | OSSEON LLC 2330 CIRCADIAN WAY Santa Rosa, CA 95407 |
| Contact | Keith Burger |
| Correspondent | Keith Burger OSSEON LLC 2330 CIRCADIAN WAY Santa Rosa, CA 95407 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450327913 | K141930 | 000 |
| 00884450327906 | K141930 | 000 |
| 10884450386757 | K141930 | 000 |
| 10884450386740 | K141930 | 000 |