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FuzeFix Mini

FDA UDI

Class I (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
FuzeFix Mini FDA UDI
Generic Name
Orthopaedic osteotome handle FDA UDI
Device Name
Non-Ratcheting Driver Handle (NOT IN USE) FDA UDI
Model / Reference
TN-FX-6020 FDA UDI
Description
Non-Ratcheting Driver Handle (NOT IN USE) FDA UDI

Identifiers

Catalog Number
TN-FX-6020 FDA UDI
Primary DI / UDI-DI
00840124518766 FDA UDI
510(k) Number
K170038 FDA UDI
FDA Product Code
GDZ FDA UDI
GMDN Term
Orthopaedic osteotome handle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic osteotome handle

FuzeFix Mini by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic osteotome handle.

Cleared under the same submission

K170038 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI 95ed421a-f7d1-4fc9-8e1e-ad15f6b18c0b 35 fields · synced May 31, 2026