The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Curvilinear Distraction System.
| Device ID | K080153 |
| 510k Number | K080153 |
| Device Name: | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980045001710 | K080153 | 000 |
| H980045001000 | K080153 | 000 |
| H980045001010 | K080153 | 000 |
| H980045001300 | K080153 | 000 |
| H980045001310 | K080153 | 000 |
| H980045001400 | K080153 | 000 |
| H980045001410 | K080153 | 000 |
| H980045001500 | K080153 | 000 |
| H980045001510 | K080153 | 000 |
| H980045001700 | K080153 | 000 |
| H980045000180 | K080153 | 000 |