The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Tsrh Anterior Spinal Screws, Staples And End Plate.
| Device ID | K883784 |
| 510k Number | K883784 |
| Device Name: | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE |
| Classification | Accessories, Fixation, Spinal Intervertebral Body |
| 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 | LYQ |
| CFR Regulation Number | 888.4540 [🔎] |
| 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 |