TranS1

FDA UDI

Class II (US FDA UDI)

by Quandary Medical Llc

Identity

Trade Name: TranS1 FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 10, 60 mm Fixation Rod FDA UDI
Model / Reference: TR1-2363 FDA UDI
Description: AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 10, 60 mm Fixation Rod FDA UDI

Identifiers

Primary DI / UDI-DI: 00815361020419 FDA UDI
510(k) Number: K102334 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vertebral body prosthesis

TranS1 by Quandary Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis.

CASCADIA™ Interbody System — K2M, INC. · Class II
CHESAPEAKE® Stabilization System — K2M, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
FORTIFY — GLOBUS MEDICAL, INC. · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
Cascadia™ Interbody System — K2M, INC. · Class II

Cleared under the same submission

K102334 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: Quandary Medical Llc

Sources (1)

FDA UDI 2417b399-377c-4bc4-8805-78c7757d1759 34 fields · synced Jun 8, 2026