Identity
- Trade Name
- FuzeFix Mini FDA UDI
- Generic Name
- Surgical depth gauge, single-use FDA UDI
- Device Name
- HL Depth Gauge FDA UDI
- Model / Reference
- TN-FX-8020 FDA UDI
- Description
- HL Depth Gauge FDA UDI
Identifiers
- Catalog Number
- TN-FX-8020 FDA UDI
- Primary DI / UDI-DI
- 00840124518735 FDA UDI
- 510(k) Number
- K170038 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 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: Surgical depth gauge, single-use
FuzeFix Mini by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, single-use.
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- General Instrument — ALPHATEC SPINE, INC. · Class I
- Solanas — ALPHATEC SPINE, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
- NuVasive — Nuvasive, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI 24de278d-2e08-4afd-981e-cafc49d94125 35 fields · synced Jun 1, 2026