The following data is part of a premarket notification filed by Theken Surgical with the FDA for Nonlinear Taper Lag Screw.
| Device ID | K994382 |
| 510k Number | K994382 |
| Device Name: | NONLINEAR TAPER LAG SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | THEKEN SURGICAL 1100 NOLA AVE. Barberton, OH 44203 |
| Contact | Lukas Eisermann |
| Correspondent | Lukas Eisermann THEKEN SURGICAL 1100 NOLA AVE. Barberton, OH 44203 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-28 |
| Decision Date | 2000-03-10 |
| Summary: | summary |