The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Twinfix Interfragmentary Compression Screw System.
| Device ID | K013775 |
| 510k Number | K013775 |
| Device Name: | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-01-08 |
| Summary: | summary |