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LapiLock

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
LapiLock FDA UDI
Generic Name
Orthopaedic bone fixation plate spacer FDA UDI
Device Name
5.0mm Spacer FDA UDI
Model / Reference
TN-LL-6505 FDA UDI
Description
5.0mm Spacer FDA UDI

Identifiers

Catalog Number
TN-LL-6505 FDA UDI
Primary DI / UDI-DI
00840124519398 FDA UDI
FDA Product Code
PLF FDA UDI
GMDN Term
Orthopaedic bone fixation plate spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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 bone fixation plate spacer

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

Similar devices

Also classified as Orthopaedic bone fixation plate spacer.

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 967409a2-050a-4db5-8d89-3b0ec022eb78 34 fields · synced May 30, 2026