Tyber Medical Trauma Screw
FDA 510(k) K192974 · Tyber Medical, LLC
510(k) numberK192974
Submission
- Device name
- Tyber Medical Trauma Screw
- Applicant
- Tyber Medical, LLC
Bethlehem, PA, US - Received
- October 24, 2019
- Decision date
- January 8, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261207 | Exalta Proximal Tibia Plating SystemHRS · Traditional | 06/12/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | 06/10/2026SE |
| K261060 | Navigated LLIF Impactable TrackerOLO · Traditional | 05/29/2026SE |
| K253042 | Tyber Medical Trauma ScrewHWC · Traditional | 04/03/2026SE |
| K252901 | Tyber Medical Trauma ScrewHWC · Traditional | 12/31/2025SE |
| K252742 | Navigated InstrumentsOLO · Traditional | 10/28/2025SE |
| K251361 | Tyber Medical Distal Radius Plating SystemHRS · Traditional | 07/30/2025SE |
| K242486 | Tyber Medical Anatomical Plating SystemHRS · Traditional | 03/19/2025SE |
| K241218 | Tyber Medical Anatomical Plating SystemHRS · Special | 05/31/2024SE |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag SystemHRS · Traditional | 12/21/2023SE |
Questions and answers
When was Tyber Medical Trauma Screw cleared by the FDA?
Tyber Medical Trauma Screw (K192974) received a 510(k) decision of Substantially Equivalent on January 8, 2020, 76 days after the submission was received.
What is the product code of K192974?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.