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FuzeFix Chamfered Screws

FDA UDI

Class I (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
FuzeFix Chamfered Screws FDA UDI
Generic Name
Periosteal elevator, single-use FDA UDI
Device Name
Periostial Elevator FDA UDI
Model / Reference
TN-CS-8065 FDA UDI
Description
Periostial Elevator FDA UDI

Identifiers

Catalog Number
TN-CS-8065 FDA UDI
Primary DI / UDI-DI
00840124513877 FDA UDI
510(k) Number
K170038 FDA UDI
FDA Product Code
HTE FDA UDI
GMDN Term
Periosteal elevator, single-use 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Periosteal elevator, single-use

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

Similar devices

Also classified as Periosteal elevator, single-use.

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 2a39736f-a483-4e33-b452-26353083c88d 35 fields · synced May 30, 2026