LapiLock

FDA UDI

Class I (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name: LapiLock FDA UDI
Generic Name: Leg friction/impact protector FDA UDI
Device Name: Met Cup Subcutaneous Triplanar Correction System FDA UDI
Model / Reference: TN-LL-7000-15I FDA UDI
Description: Met Cup Subcutaneous Triplanar Correction System FDA UDI

Identifiers

Catalog Number: TN-LL-7000-15I FDA UDI
Primary DI / UDI-DI: 00840124519336 FDA UDI
FDA Product Code: FMP FDA UDI
GMDN Term: Leg friction/impact protector FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Leg friction/impact protector

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

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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 cc7a38bf-fc27-4e6f-a985-51c963bd99df 34 fields · synced May 30, 2026