The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Small External Fixation System, Synthes Large External Fixation System.
| Device ID | K122455 |
| 510k Number | K122455 |
| Device Name: | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Angela F Lassandro |
| Correspondent | Angela F Lassandro SYNTHES 1301 Goshen Parkway 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 | 2012-08-13 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793949940 | K122455 | 000 |
| H6793949930 | K122455 | 000 |
| H6793949920 | K122455 | 000 |
| H6793949910 | K122455 | 000 |
| H679394970 | K122455 | 000 |
| H6793947990 | K122455 | 000 |
| H6793947980 | K122455 | 000 |
| H6793947970 | K122455 | 000 |
| H6793947960 | K122455 | 000 |