The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Craniomaxillofacial Distraction System.
| Device ID | K060138 |
| 510k Number | K060138 |
| Device Name: | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung 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 | 2006-01-19 |
| Decision Date | 2006-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980043150000 | K060138 | 000 |
| H980043150630 | K060138 | 000 |
| H980043150640 | K060138 | 000 |
| H980043150650 | K060138 | 000 |
| H980043150660 | K060138 | 000 |
| H980043150670 | K060138 | 000 |
| H980043150680 | K060138 | 000 |
| H980043151040 | K060138 | 000 |
| H980043151080 | K060138 | 000 |
| H980043151120 | K060138 | 000 |
| H980043151250 | K060138 | 000 |
| H980043151270 | K060138 | 000 |
| H980043151320 | K060138 | 000 |
| H980043150560 | K060138 | 000 |
| H980043150550 | K060138 | 000 |
| H980043150540 | K060138 | 000 |
| H980043150010 | K060138 | 000 |
| H980043150030 | K060138 | 000 |
| H980043150040 | K060138 | 000 |
| H980043150050 | K060138 | 000 |
| H980043150060 | K060138 | 000 |
| H980043150230 | K060138 | 000 |
| H980043150240 | K060138 | 000 |
| H980043150250 | K060138 | 000 |
| H980043150260 | K060138 | 000 |
| H980043150270 | K060138 | 000 |
| H980043150280 | K060138 | 000 |
| H980043150530 | K060138 | 000 |
| H980043152010 | K060138 | 000 |
| H980043152020 | K060138 | 000 |
| H980043154030 | K060138 | 000 |
| H980043154110 | K060138 | 000 |
| H980043154120 | K060138 | 000 |
| H980043154130 | K060138 | 000 |
| H980043154210 | K060138 | 000 |
| H980043154220 | K060138 | 000 |
| H980043154230 | K060138 | 000 |
| H980043155010 | K060138 | 000 |
| H980043155020 | K060138 | 000 |
| H980043155030 | K060138 | 000 |
| H980043155110 | K060138 | 000 |
| H980043155120 | K060138 | 000 |
| H980043154020 | K060138 | 000 |
| H980043154010 | K060138 | 000 |
| H980043153230 | K060138 | 000 |
| H980043152030 | K060138 | 000 |
| H980043152110 | K060138 | 000 |
| H980043152120 | K060138 | 000 |
| H980043152130 | K060138 | 000 |
| H980043153010 | K060138 | 000 |
| H980043153020 | K060138 | 000 |
| H980043153030 | K060138 | 000 |
| H980043153110 | K060138 | 000 |
| H980043153120 | K060138 | 000 |
| H980043153130 | K060138 | 000 |
| H980043153210 | K060138 | 000 |
| H980043153220 | K060138 | 000 |
| H980043155130 | K060138 | 000 |