The following data is part of a premarket notification filed by Osteocentric Extremities, Llc with the FDA for Headless Compression Screw System.
| Device ID | K200259 |
| 510k Number | K200259 |
| Device Name: | Headless Compression Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | OsteoCentric Extremities, LLC 5113 Southwest Parkway, Suite 150 Austin, TX 78735 |
| Contact | Todd Evans |
| Correspondent | Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-05-04 |