The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Tsrh Sacral Spinal Screw.
| Device ID | K883783 |
| 510k Number | K883783 |
| Device Name: | TSRH SACRAL SPINAL SCREW |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1989-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978039718 | K883783 | 000 |
| 00673978039428 | K883783 | 000 |
| 00673978039411 | K883783 | 000 |
| 00673978039404 | K883783 | 000 |
| 00673978039381 | K883783 | 000 |
| 00673978039374 | K883783 | 000 |
| 00673978039350 | K883783 | 000 |
| 00673978039336 | K883783 | 000 |