Identity
- Trade Name
- FuzeFix Chamfered Screws FDA UDI
- Generic Name
- Orthopaedic bone-reduction tool FDA UDI
- Device Name
- Tunneling Tool FDA UDI
- Model / Reference
- TN-CS-8500 FDA UDI
- Description
- Tunneling Tool FDA UDI
Identifiers
- Catalog Number
- TN-CS-8500 FDA UDI
- Primary DI / UDI-DI
- 00840124520493 FDA UDI
- 510(k) Number
- K170038 FDA UDI
- FDA Product Code
- QBO FDA UDI
- GMDN Term
- Orthopaedic bone-reduction tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4505 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Orthopaedic bone-reduction tool
FuzeFix Chamfered Screws by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone-reduction tool.
- TRIGEN MAX — Smith & Nephew, Inc. · Class II
- REDUCTION TOOL SMALL BONE NAIL — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- Tools - WFS (C) — Trimed, INC. · Class I
- TRIGEN — Smith & Nephew, Inc. · Class II
- PRECICE® Trauma Nail System — NuVasive Specialized Orthopedics, Inc. · Class I
- Reduction Rod — Double Medical Technology Inc. · Class II
- MULTILOC — Synthes · Class II
- TRIGEN — Smith & Nephew, Inc. · Class II
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 6b339510-832d-4480-b468-533a511a3fb5 35 fields · synced May 30, 2026