The following data is part of a premarket notification filed by Orthos Limited with the FDA for Osteoboost-bma.
| Device ID | K062260 |
| 510k Number | K062260 |
| Device Name: | OSTEOBOOST-BMA |
| Classification | Syringe, Piston |
| Applicant | ORTHOS LIMITED 3 THE STABLES LEIGH CT PILL RD ABBOTS LEIGH Bristol, North Somerset, GB Bs8 3ra |
| Contact | Alan Rorke |
| Correspondent | Alan Rorke ORTHOS LIMITED 3 THE STABLES LEIGH CT PILL RD ABBOTS LEIGH Bristol, North Somerset, GB Bs8 3ra |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2006-10-26 |
| Summary: | summary |