The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Orthodontic Bone Anchor System.
| Device ID | K063473 |
| 510k Number | K063473 |
| Device Name: | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson 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 | 2006-11-16 |
| Decision Date | 2007-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004500028050 | K063473 | 000 |
| H980045000080 | K063473 | 000 |
| H980045000100 | K063473 | 000 |
| H980045000120 | K063473 | 000 |
| H980045000130 | K063473 | 000 |
| H980045000140 | K063473 | 000 |
| H980045000150 | K063473 | 000 |
| H980045000160 | K063473 | 000 |
| H980045000170 | K063473 | 000 |
| H98004500024010 | K063473 | 000 |
| H98004500026010 | K063473 | 000 |
| H98004500028010 | K063473 | 000 |
| H98004500034010 | K063473 | 000 |
| H98004500036010 | K063473 | 000 |
| H98004500038010 | K063473 | 000 |
| H98004500024050 | K063473 | 000 |
| H98004500026050 | K063473 | 000 |
| H980045000060 | K063473 | 000 |