Identity
- Trade Name
- QWIX FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- The QWIX stabilization screw is a cannulated titanium alloy screw with a long non-threaded shaft, allowing optimal compression and has a self-tapping screw tip. These features enable its use in bone fixation. Its length can vary from 10 to 34mm for the 3.0mm diameter QWIX stabilization screw. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile. FDA UDI
- Model / Reference
- 111328SND FDA UDI
- Description
- The QWIX stabilization screw is a cannulated titanium alloy screw with a long non-threaded shaft, allowing optimal compression and has a self-tapping screw tip. These features enable its use in bone fixation. Its length can vary from 10 to 34mm for the 3.0mm diameter QWIX stabilization screw. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered sterile. FDA UDI
Identifiers
- Catalog Number
- 111328SND FDA UDI
- Primary DI / UDI-DI
- 10381780046684 FDA UDI
- 510(k) Number
- K050346 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
Qwix by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- A.L.P.S.CORTICAL SCREW — Biomet Orthopedics, Inc. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K050346 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 0bf0fba5-134b-4ec2-8264-c549c9ed729f 39 fields · synced May 30, 2026