The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Headless Compression Screw System.
| Device ID | K143624 |
| 510k Number | K143624 |
| Device Name: | Headless Compression Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Contact | Ana M. Escagedo |
| Correspondent | Ana M. Escagedo SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-01-13 |
| Summary: | summary |