The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 90 Degree Screwdriver.
| Device ID | K082649 |
| 510k Number | K082649 |
| Device Name: | SYNTHES 90 DEGREE SCREWDRIVER |
| Classification | Drill, Bone, Powered |
| 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 | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2009-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611819111707 | K082649 | 000 |
| H980035050300 | K082649 | 000 |
| H980035050320 | K082649 | 000 |
| H980035050350 | K082649 | 000 |
| H980035050360 | K082649 | 000 |
| H980035050370 | K082649 | 000 |
| H980035050410 | K082649 | 000 |
| H980035050440 | K082649 | 000 |
| H980035050470 | K082649 | 000 |
| H980035050540 | K082649 | 000 |
| H980035050270 | K082649 | 000 |
| H980035050260 | K082649 | 000 |
| 07611819187528 | K082649 | 000 |
| 07611819111776 | K082649 | 000 |
| 07611819187474 | K082649 | 000 |
| 07611819187481 | K082649 | 000 |
| 07611819187498 | K082649 | 000 |
| H980035050060 | K082649 | 000 |
| H980035050070 | K082649 | 000 |
| H980035050080 | K082649 | 000 |
| H980035050100 | K082649 | 000 |
| 07611819187511 | K082649 | 000 |
| H980035050570 | K082649 | 000 |
| H980035050650 | K082649 | 000 |
| H980035050920 | K082649 | 000 |
| H980035050940 | K082649 | 000 |
| H980035051410 | K082649 | 000 |
| H980035051440 | K082649 | 000 |
| H980035051470 | K082649 | 000 |
| H980035051650 | K082649 | 000 |
| H980035051660 | K082649 | 000 |
| H980035051670 | K082649 | 000 |
| 07611819829459 | K082649 | 000 |
| H980035050910 | K082649 | 000 |
| H980035050870 | K082649 | 000 |
| H980035050860 | K082649 | 000 |
| H980035050660 | K082649 | 000 |
| H980035050670 | K082649 | 000 |
| H980035050750 | K082649 | 000 |
| H980035050760 | K082649 | 000 |
| H980035050780 | K082649 | 000 |
| H980035050810 | K082649 | 000 |
| H980035050820 | K082649 | 000 |
| H980035050840 | K082649 | 000 |
| H980035050850 | K082649 | 000 |
| 07611819197480 | K082649 | 000 |