The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Reprocessed External Fixation Devices.
| Device ID | K033158 |
| 510k Number | K033158 |
| Device Name: | SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Anglela J Silvestri |
| Correspondent | Anglela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679394790 | K033158 | 000 |
| H6793937320 | K033158 | 000 |
| H6793937340 | K033158 | 000 |
| H6793937350 | K033158 | 000 |
| H6793937360 | K033158 | 000 |
| H6793937370 | K033158 | 000 |
| H679394800 | K033158 | 000 |
| H679394810 | K033158 | 000 |
| H679394820 | K033158 | 000 |
| H679394830 | K033158 | 000 |
| H6793937310 | K033158 | 000 |
| H6793937220 | K033158 | 000 |
| H679393360 | K033158 | 000 |
| H6793934360 | K033158 | 000 |
| H6793934640 | K033158 | 000 |
| H679393550 | K033158 | 000 |
| H679393560 | K033158 | 000 |
| H679393570 | K033158 | 000 |
| H679393640 | K033158 | 000 |
| H679393660 | K033158 | 000 |
| H6793937210 | K033158 | 000 |
| H679394840 | K033158 | 000 |
| H679394850 | K033158 | 000 |
| H6793951110 | K033158 | 000 |
| H6793951250 | K033158 | 000 |
| H6793951260 | K033158 | 000 |
| H679395540 | K033158 | 000 |
| H679395550 | K033158 | 000 |
| H679395580 | K033158 | 000 |
| H6793951330 | K033158 | 000 |
| H6793951340 | K033158 | 000 |
| H679SD3948700 | K033158 | 000 |
| H6793951090 | K033158 | 000 |
| H6793951070 | K033158 | 000 |
| H679394860 | K033158 | 000 |
| H679394870 | K033158 | 000 |
| H679394880 | K033158 | 000 |
| H679394890 | K033158 | 000 |
| H679394900 | K033158 | 000 |
| H679394910 | K033158 | 000 |
| H679394920 | K033158 | 000 |
| H6793951030 | K033158 | 000 |
| H6793951050 | K033158 | 000 |
| H679393540 | K033158 | 000 |