The following data is part of a premarket notification filed by Terray Manufacturing, Inc. with the FDA for Casf Cancellous Bone Screw, Bt650.
| Device ID | K882934 |
| 510k Number | K882934 |
| Device Name: | CASF CANCELLOUS BONE SCREW, BT650 |
| Classification | Screw, Fixation, Bone |
| Applicant | TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
| Contact | Judy Wilson |
| Correspondent | Judy Wilson TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-13 |
| Decision Date | 1988-10-13 |