STABILIZATION SCREW
FDA 510(k) clearance K131920 · decided 2014-05-01
Clearance details
- K-number
- K131920
- Device name
- STABILIZATION SCREW
- Applicant
- In2bones Sas
- Decision
- Substantially Equivalent
- Date received
- 2013-06-26
- Decision date
- 2014-05-01
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Potomac, MD, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GFS - Sterile Screws and Top Hat (K253858) | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
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| Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (K260809) | Arthrex, Inc. | 2026-06-25 |
| VEOFIX Snap Off Screw (K253108) | Steps Ortho | 2026-06-05 |
| CoLink® & CoLag® Non-Sterile Screws (K261154) | In2Bones USA, LLC | 2026-05-30 |
| TriMed Compression Screws (K261241) | TriMed, Inc. | 2026-05-14 |
| Arthrex Beaming System (K254215) | Arthrex, Inc. | 2026-05-08 |
| OSSIOfiber® Threaded Trimmable Fixation Nail (K254077) | OSSIO , Ltd. | 2026-05-01 |
| TITAN Nail; APTUS K-Wire System (K260934) | Medartis AG | 2026-04-17 |
| CoAptix S System (K252699) | University of Utah, Department of Orthopaedics | 2026-04-10 |
| Tyber Medical Trauma Screw (K253042) | Tyber Medical, LLC | 2026-04-03 |
| DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (K254110) | MedShape, Inc. | 2026-03-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 recall (Z-1319-2024) | In2Bones, SAS | 2024-03-20 |
| I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 recall (Z-1320-2024) | In2Bones, SAS | 2024-03-20 |
| IBS - Osteosynthesis screws for bone fixation Model S25 ST014. recall (Z-0397-2016) | In2Bones, SAS | 2015-12-09 |