The following data is part of a premarket notification filed by Orthos (uk) Limited with the FDA for Bgran Synthetic Osteoconductive Scaffoid.
| Device ID | K041616 |
| 510k Number | K041616 |
| Device Name: | BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOS (UK) LIMITED THE STABLES, LEIGH COURT ABBOTS LEIGH Bristol North Somerset, GB Bs8 3ra |
| Contact | Alan Rorke |
| Correspondent | Alan Rorke ORTHOS (UK) LIMITED THE STABLES, LEIGH COURT ABBOTS LEIGH Bristol North Somerset, GB Bs8 3ra |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-08-25 |
| Summary: | summary |