OrthoPediatrics ACL Reconstruction System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: OrthoPediatrics ACL Reconstruction System FDA UDI
Generic Name: Ligament bone anchor FDA UDI
Device Name: ArmorLink 10.0mm FDA UDI
Model / Reference: 10-1008-1100 FDA UDI
Description: ArmorLink 10.0mm FDA UDI

Identifiers

Catalog Number: 10-1008-1100 FDA UDI
Primary DI / UDI-DI: 00841132122181 FDA UDI
510(k) Number: K130217 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Ligament bone anchor 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

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Ligament bone anchor

OrthoPediatrics ACL Reconstruction System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ligament bone anchor.

EZLOC — Biomet Sports Medicine · Class II
MINI BONE MULCH — Biomet Sports Medicine · Class II
EZLOC™ — Biomet Orthopedics, Inc. · Class II
JUGGERKNOT — Biomet Orthopedics, Inc. · Class II
M-ARS ACL: Anatomic Ribbon Surgery System — Medacta International · Class II
TITANIUM INTERFERENCE SCREW — Biomet Sports Medicine · Class II
AXL CROSSPIN — Biomet Sports Medicine · Class II
Corifix Ligament Anchor Screw — CORIN LTD · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI 815e9bf2-19dc-4d96-8838-64c299ba097e 36 fields · synced May 30, 2026