The following data is part of a premarket notification filed by Theken Surgical with the FDA for Dogbone Acfs.
| Device ID | K994383 |
| 510k Number | K994383 |
| Device Name: | DOGBONE ACFS |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-28 |
| Decision Date | 2000-02-04 |
| Summary: | summary |