The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Large External Fixation, Mr Conditional.
| Device ID | K082650 |
| 510k Number | K082650 |
| Device Name: | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Jill R Sherman |
| Correspondent | Jill R Sherman SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792944550 | K082650 | 000 |
| H679294730 | K082650 | 000 |
| H679294740 | K082650 | 000 |
| H679294750 | K082650 | 000 |
| H679294760 | K082650 | 000 |
| H6792947740 | K082650 | 000 |
| H6792947750 | K082650 | 000 |
| H6792947760 | K082650 | 000 |
| H6792947770 | K082650 | 000 |
| H6792947780 | K082650 | 000 |
| H679294720 | K082650 | 000 |
| H679294710 | K082650 | 000 |
| H679294530 | K082650 | 000 |
| H679294540 | K082650 | 000 |
| H679294550 | K082650 | 000 |
| H679294560 | K082650 | 000 |
| H679294570 | K082650 | 000 |
| H679294650 | K082650 | 000 |
| H679294660 | K082650 | 000 |
| H679294670 | K082650 | 000 |
| H679294680 | K082650 | 000 |
| H6792947790 | K082650 | 000 |
| H6792947820 | K082650 | 000 |
| H6792947830 | K082650 | 000 |
| H6794947750 | K082650 | 000 |
| H6794947760 | K082650 | 000 |
| H6794947770 | K082650 | 000 |
| H6794947710 | K082650 | 000 |
| H679294300 | K082650 | 000 |
| H6794947720 | K082650 | 000 |
| H67903301010S0 | K082650 | 000 |
| H67903301012S0 | K082650 | 000 |
| H67903301013S0 | K082650 | 000 |
| H6792949500 | K082650 | 000 |
| H6792947980 | K082650 | 000 |
| H6792947840 | K082650 | 000 |
| H6792947850 | K082650 | 000 |
| H6792947860 | K082650 | 000 |
| H6792947880 | K082650 | 000 |
| H6792947920 | K082650 | 000 |
| H6792947930 | K082650 | 000 |
| H6792947940 | K082650 | 000 |
| H6792947950 | K082650 | 000 |
| H6792947960 | K082650 | 000 |
| H67903301011S0 | K082650 | 000 |