The following data is part of a premarket notification filed by Levtech, Inc. with the FDA for Levtech Titanium Bone Wire.
| Device ID | K910128 |
| 510k Number | K910128 |
| Device Name: | LEVTECH TITANIUM BONE WIRE |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-06-18 |