The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Translating Maxillary Distractor.
| Device ID | K020505 |
| 510k Number | K020505 |
| Device Name: | SYNTHES TRANSLATING MAXILLARY DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew H Hull |
| Correspondent | Matthew H Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-15 |
| Decision Date | 2002-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9802880650 | K020505 | 000 |
| H9802880380 | K020505 | 000 |
| H9802880280 | K020505 | 000 |
| H9802880270 | K020505 | 000 |
| H9802880260 | K020505 | 000 |
| H9802880250 | K020505 | 000 |
| H980SD2880430 | K020505 | 000 |
| H980SD2880420 | K020505 | 000 |
| H980SD2880390 | K020505 | 000 |
| H9802880390 | K020505 | 000 |
| H9802880400 | K020505 | 000 |
| H9802880420 | K020505 | 000 |
| H9802880590 | K020505 | 000 |
| H9802880580 | K020505 | 000 |
| H9802880560 | K020505 | 000 |
| H9802880550 | K020505 | 000 |
| H9802880530 | K020505 | 000 |
| H9802880520 | K020505 | 000 |
| H9802880440 | K020505 | 000 |
| H9802880430 | K020505 | 000 |
| H980SD2880380 | K020505 | 000 |