Identity
- Trade Name
- FuzeFix Chamfered Screws FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- Cannulated Driver 2.5mm FDA UDI
- Model / Reference
- CD-CS-3025 FDA UDI
- Description
- Cannulated Driver 2.5mm FDA UDI
Identifiers
- Catalog Number
- CD-CS-3025 FDA UDI
- Primary DI / UDI-DI
- 00840124514416 FDA UDI
- 510(k) Number
- K170038 FDA UDI
- FDA Product Code
- DZJ FDA UDI
- GMDN Term
- Surgical screwdriver, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, single-use
FuzeFix Chamfered Screws are a high-quality, single-use surgical screwdriver designed for temporary fixation of implants during complex surgical procedures. These cannulated driver screws feature a non-powered tool design that allows for precise torque control and reduced tissue damage.
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Also classified as Surgical screwdriver, single-use.
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Cleared under the same submission
K170038 also covers:
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- FuzeFix Jones — FUSION ORTHOPEDICS, LLC
- FuzeFix Jones — FUSION ORTHOPEDICS, LLC
- FuzeFix Jones — FUSION ORTHOPEDICS, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI c6ebe3e9-951c-40dd-b972-5f93125f0416 35 fields · synced Jun 24, 2026