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 |