Tyber Medical Trauma Screw— 510(k) K253042
Substantially EquivalentTyber Medical, LLC
FDA 510(k) clearance K253042 for Tyber Medical Trauma Screw, Substantially Equivalent on 2026-04-03. Applicant: Tyber Medical, LLC. Device class: 2.
Summary
The Tyber Medical Trauma Screw, from Tyber Medical, LLC, is filed under product code HWC (Screw, Fixation, Bone). The record gives nothing beyond that generic name and the code name.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Tyber Medical filed from Bethlehem, Pennsylvania. The decision came 193 calendar days after FDA received it (September 22, 2025 to April 3, 2026).
Clearance details
- Applicant
- Tyber Medical, LLC
- Product code
- Product code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code HWC
view allMore clearances from Tyber Medical, LLC
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.