The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Tsrh Variable Angle Sacral Screw.
| Device ID | K904243 |
| 510k Number | K904243 |
| Device Name: | TSRH VARIABLE ANGLE SACRAL SCREW |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Frank Lewis |
| Correspondent | Frank Lewis DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| 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 | 1990-09-14 |
| Decision Date | 1992-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978132877 | K904243 | 000 |
| 00673978049687 | K904243 | 000 |
| 00673978049670 | K904243 | 000 |
| 00673978049663 | K904243 | 000 |
| 00673978049656 | K904243 | 000 |
| 00721902981166 | K904243 | 000 |
| 00721902981159 | K904243 | 000 |
| 00721902981128 | K904243 | 000 |
| 00721902717635 | K904243 | 000 |
| 00673978049694 | K904243 | 000 |
| 00673978049700 | K904243 | 000 |
| 00673978049717 | K904243 | 000 |
| 00673978132860 | K904243 | 000 |
| 00673978049793 | K904243 | 000 |
| 00673978049786 | K904243 | 000 |
| 00673978049779 | K904243 | 000 |
| 00673978049762 | K904243 | 000 |
| 00673978049755 | K904243 | 000 |
| 00673978049748 | K904243 | 000 |
| 00673978049724 | K904243 | 000 |
| 00721902717628 | K904243 | 000 |