The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Ariculated Tension Device Synthes Ten.
| Device ID | K792253 |
| 510k Number | K792253 |
| Device Name: | ARICULATED TENSION DEVICE SYNTHES TEN |
| Classification | Instrument, Compression |
| Applicant | SYNTHES (USA) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HWN |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-07 |
| Decision Date | 1979-12-05 |