The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Tsrh(r) Top Tight T-bolt-vari Angle/screw/paragon.
| Device ID | K933205 |
| 510k Number | K933205 |
| Device Name: | TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne 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 | 1993-07-01 |
| Decision Date | 1994-05-04 |