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IntraLock

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
IntraLock FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, single-use FDA UDI
Device Name
Guided Impactor Nail FDA UDI
Model / Reference
TN-IL-5050 FDA UDI
Description
Guided Impactor Nail FDA UDI

Identifiers

Catalog Number
TN-IL-5050 FDA UDI
Primary DI / UDI-DI
00840124519169 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, single-use 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

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: General external orthopaedic fixation system implantation kit, single-use

IntraLock by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, single-use.

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 4f89b0b4-6220-4665-b664-795974ca58bd 34 fields · synced May 30, 2026