The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Orthodontic Bone Anchor System.
| Device ID | K093299 |
| 510k Number | K093299 |
| Device Name: | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-21 |
| Decision Date | 2010-12-16 |
| Summary: | summary |