The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes External Midface Distractor.
| Device ID | K040083 |
| 510k Number | K040083 |
| Device Name: | SYNTHES EXTERNAL MIDFACE DISTRACTOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-15 |
| Decision Date | 2004-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9803901330 | K040083 | 000 |
| H980033070100 | K040083 | 000 |
| H980033071050 | K040083 | 000 |
| H980033071120 | K040083 | 000 |
| H980043070010 | K040083 | 000 |
| H980043070080 | K040083 | 000 |
| H980043071080 | K040083 | 000 |
| H980043071110 | K040083 | 000 |
| H980045000000 | K040083 | 000 |
| H980045000010 | K040083 | 000 |
| H980045000020 | K040083 | 000 |
| H9803901300 | K040083 | 000 |
| H9803901310 | K040083 | 000 |
| H9803901320 | K040083 | 000 |
| H980033070010 | K040083 | 000 |