Identity
- Trade Name
- FuzeFix Mini FDA UDI
- Generic Name
- Surgical screwdriver, single-use, non-sterile FDA UDI
- Device Name
- Driver Torx 2.5mm FDA UDI
- Model / Reference
- CD-FX-3025 FDA UDI
- Description
- Driver Torx 2.5mm FDA UDI
Identifiers
- Catalog Number
- CD-FX-3025 FDA UDI
- Primary DI / UDI-DI
- 00819034021567 FDA UDI
- 510(k) Number
- K170038 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical screwdriver, single-use, non-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
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, non-sterile
FuzeFix Mini by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, single-use, non-sterile.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
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- EASYOUT — Biomet Orthopedics, Inc. · Class I
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- T10 Screwdriver, Short — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- HEX EXTRACTOR, LONG HUDSON — Biomet Orthopedics, Inc. · Class I
- EASY OUT, S-COUPLE — Biomet Orthopedics, Inc. · Class I
- AOS Hex Screw Driver 2.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI 7f853219-5c73-41f2-b5ce-5da0256b7d1e 35 fields · synced May 30, 2026