STABILIZATION SCREW
FDA 510(k) clearance K050346 · decided 2005-03-17
Clearance details
- K-number
- K050346
- Device name
- STABILIZATION SCREW
- Applicant
- New Deal, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-11
- Decision date
- 2005-03-17
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Planisboro, NJ, 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 |
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| 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 |
|---|---|---|
| Qwix 4.3mm Stabilization Screws - 32mm recall (Z-1253-2010) | Integra LifeSciences Corporation | 2010-04-07 |
| Qwix 4.3mm Stabilization Screws - 34mm recall (Z-1254-2010) | Integra LifeSciences Corporation | 2010-04-07 |
| QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of recall (Z-1445-2008) | Integra LifeSciences Corp. | 2008-08-15 |
| QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of recall (Z-1446-2008) | Integra LifeSciences Corp. | 2008-08-15 |