The following data is part of a premarket notification filed by Levtech, Inc. with the FDA for Levtech Bone Screw.
| Device ID | K901144 |
| 510k Number | K901144 |
| Device Name: | LEVTECH BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | LEVTECH, INC. P.O. BOX 516 Jacksonville, FL 32201 |
| Contact | Levon Pentecost |
| Correspondent | Levon Pentecost LEVTECH, INC. P.O. BOX 516 Jacksonville, FL 32201 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-10-10 |