The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Air Pen Drive (apd) System.
| Device ID | K093361 |
| 510k Number | K093361 |
| Device Name: | SYNTHES AIR PEN DRIVE (APD) SYSTEM |
| Classification | Motor, Drill, Pneumatic |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Jill Yelton |
| Correspondent | Jill Yelton SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-28 |
| Decision Date | 2010-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611819414785 | K093361 | 000 |
| 07611819830905 | K093361 | 000 |
| 07611819831513 | K093361 | 000 |
| 07611819831520 | K093361 | 000 |
| 07611819831537 | K093361 | 000 |
| 07611819831544 | K093361 | 000 |
| 07611819831551 | K093361 | 000 |
| 07611819831568 | K093361 | 000 |
| 07611819831575 | K093361 | 000 |
| 07611819831582 | K093361 | 000 |
| 07611819831599 | K093361 | 000 |
| 07611819831605 | K093361 | 000 |
| 07611819868113 | K093361 | 000 |
| 07611819414778 | K093361 | 000 |
| 07611819830899 | K093361 | 000 |