The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Tsrh H/m Torque Limiting Wrench.
| Device ID | K880214 |
| 510k Number | K880214 |
| Device Name: | TSRH H/M TORQUE LIMITING WRENCH |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
| Contact | James Ritter |
| Correspondent | James Ritter WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-19 |
| Decision Date | 1988-02-18 |