The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Maxillary Distractor.
| Device ID | K003393 |
| 510k Number | K003393 |
| Device Name: | MAXILLARY DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9802880190 | K003393 | 000 |
| H9802015060 | K003393 | 000 |
| H980201804980 | K003393 | 000 |
| H9802880010 | K003393 | 000 |
| H9802880020 | K003393 | 000 |
| H9802880030 | K003393 | 000 |
| H9802880050 | K003393 | 000 |
| H9802880060 | K003393 | 000 |
| H9802880070 | K003393 | 000 |
| H9802880100 | K003393 | 000 |
| H9802880110 | K003393 | 000 |
| H9802880140 | K003393 | 000 |
| H9802880150 | K003393 | 000 |
| H980033070020 | K003393 | 000 |