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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
Component 15 Long Triplanar Correction System FDA UDI
Model / Reference
TN-LL-7000-15L FDA UDI
Description
Component 15 Long Triplanar Correction System FDA UDI

Identifiers

Catalog Number
TN-LL-7000-15L FDA UDI
Primary DI / UDI-DI
00840124519305 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

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: Leg friction/impact protector

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

Similar devices

Also classified as Leg friction/impact protector.

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 beb3f7a6-038c-4218-ace1-1cf3b5061591 34 fields · synced Jun 8, 2026