The following data is part of a premarket notification filed by Levtech, Inc. with the FDA for Halifax Spinal Clamp.
| Device ID | K850039 |
| 510k Number | K850039 |
| Device Name: | HALIFAX SPINAL CLAMP |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LEVTECH, INC. P.O. BOX 516 Jacksonville, FL 32201 |
| Contact | Pentecost |
| Correspondent | Pentecost LEVTECH, INC. P.O. BOX 516 Jacksonville, FL 32201 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-07 |
| Decision Date | 1985-05-29 |