The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Curvilinear Distraction System.
| Device ID | K121502 |
| 510k Number | K121502 |
| Device Name: | SYNTHES CURVILINEAR DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES INC 1301 Goshen Parkway 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 | 2012-05-21 |
| Decision Date | 2012-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980045002710 | K121502 | 000 |
| H980045002010 | K121502 | 000 |
| H980045002180 | K121502 | 000 |
| H980045002300 | K121502 | 000 |
| H980045002310 | K121502 | 000 |
| H980045002400 | K121502 | 000 |
| H980045002410 | K121502 | 000 |
| H980045002500 | K121502 | 000 |
| H980045002510 | K121502 | 000 |
| H980045002700 | K121502 | 000 |
| H980045002000 | K121502 | 000 |