The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Tsrh H/m Hook, Eyebolt/lock Nut Assem., Spinal Rod.
| Device ID | K880215 |
| 510k Number | K880215 |
| Device Name: | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978049311 | K880215 | 000 |
| 00673978048796 | K880215 | 000 |
| 00673978048789 | K880215 | 000 |
| 00673978048772 | K880215 | 000 |
| 00673978048765 | K880215 | 000 |
| 00673978048741 | K880215 | 000 |
| 00673978048734 | K880215 | 000 |
| 00673978048727 | K880215 | 000 |
| 00673978048680 | K880215 | 000 |
| 00673978047218 | K880215 | 000 |
| 00673978048802 | K880215 | 000 |
| 00673978048819 | K880215 | 000 |
| 00673978048826 | K880215 | 000 |
| 00673978049298 | K880215 | 000 |
| 00673978049274 | K880215 | 000 |
| 00673978049236 | K880215 | 000 |
| 00673978049175 | K880215 | 000 |
| 00673978049113 | K880215 | 000 |
| 00673978048864 | K880215 | 000 |
| 00673978048857 | K880215 | 000 |
| 00673978048840 | K880215 | 000 |
| 00673978048833 | K880215 | 000 |
| 00673978047201 | K880215 | 000 |