DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: GUIDE 2150212 O51 SCREW GUIDE 12MM FDA UDI
Model / Reference: 2150212 FDA UDI
Description: GUIDE 2150212 O51 SCREW GUIDE 12MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169524781 FDA UDI
510(k) Number: K150135 FDA UDI
FDA Product Code: OVD FDA UDI
MAX FDA UDI
KWQ FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implantation sleeve, reusable

DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implantation sleeve, reusable.

Arthrex® — Arthrex, Inc. · Class I
gSource — GSOURCE, LLC. · Class I
FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
Jet-X — Smith & Nephew, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I

Cleared under the same submission

K150135 also covers:

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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI a295197d-75fe-4468-ad9d-3a00ce555d5b 36 fields · synced Jun 6, 2026