The following data is part of a premarket notification filed by Special Devices, Inc. with the FDA for Sd Trans-osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12mm 16mm 1m.
| Device ID | K982354 |
| 510k Number | K982354 |
| Device Name: | SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M |
| Classification | Washer, Bolt Nut |
| Applicant | SPECIAL DEVICES, INC. 12493 OLD ROUGH AND READY HWY. Grass Valley, CA 95945 |
| Contact | Joseph J Spranza |
| Correspondent | Joseph J Spranza SPECIAL DEVICES, INC. 12493 OLD ROUGH AND READY HWY. Grass Valley, CA 95945 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-06 |
| Decision Date | 1998-11-23 |