The following data is part of a premarket notification filed by Sign Fracture Care International with the FDA for Sign Compression Screw System.
| Device ID | K153759 |
| 510k Number | K153759 |
| Device Name: | SIGN Compression Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | SIGN FRACTURE CARE INTERNATIONAL 451 Hills Street, Suite B Richland, WA 99354 |
| Contact | Rob R. Teeter |
| Correspondent | Robert Schmitt SIGN FRACTURE CARE INTERNATIONAL 451 Hills Street, Suite B Richland, WA 99354 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2016-02-25 |
| Summary: | summary |