510(k) K041356
- Device
- ARTHREX TENODESIS SCREW FAMILY
- Applicant
- ARTHREX, INC.
- 510(k) number
- K041356
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-04
- Date received
- 2004-05-20
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Clearance type
- Traditional
- Third party reviewed
- No
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|---|---|---|---|
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| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025-11-06 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025-08-29 |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025-08-27 |
Legacy Summary#
summary
FDA Review#
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