Identity
- Trade Name
- FuzeFix Large FDA UDI
- Generic Name
- Surgical drill guide, single-use, non-sterile FDA UDI
- Device Name
- Parallel Wire Guide HD 5.5mm FDA UDI
- Model / Reference
- TN-FX-7095 FDA UDI
- Description
- Parallel Wire Guide HD 5.5mm FDA UDI
Identifiers
- Catalog Number
- TN-FX-7095 FDA UDI
- Primary DI / UDI-DI
- 00819034027286 FDA UDI
- 510(k) Number
- K170038 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical drill guide, 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 drill guide, single-use, non-sterile
FuzeFix Large by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, single-use, non-sterile.
- HBS FT RELIEF DRILL 1.0 — BIOPRO, INC. · Class I
- Drill bit AO QC 3.2 x 145/120mm, Sterile — BIOPRO, INC. · Class I
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- HBS FT RELIEF DRILL 1.2 — BIOPRO, INC. · Class I
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- FuzeFix Large — FUSION ORTHOPEDICS, LLC · 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 1a93382c-3381-493d-9b64-4624d5680beb 35 fields · synced May 30, 2026