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VariLift-L

FDA UDI

Class II (US FDA UDI)

by Wenzel Spine

Identity

Trade Name
VariLift-L FDA UDI
Generic Name
Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Device Name
13/15mm Retainer FDA UDI
Model / Reference
CIE2-A202 FDA UDI
Description
13/15mm Retainer FDA UDI

Identifiers

Primary DI / UDI-DI
00813210020450 FDA UDI
510(k) Number
K131296 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Orthopaedic implant-instrument extension adaptor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant-instrument extension adaptor, reusable

VariLift-L by Wenzel Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant-instrument extension adaptor, reusable.

Cleared under the same submission

K131296 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wenzel Spine

Sources (1)

  • FDA UDI 648a10e6-e40f-4c05-89b8-7b8e0c0a7f77 35 fields · synced Jun 8, 2026