DUALXS T/PLIF 15 DEG x 8-11MM

FDA UDI

Class II (US FDA UDI)

by Amplify Surgical

Identity

Trade Name: DUALXS T/PLIF 15 DEG x 8-11MM FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 8 Expanded Height (mm): 11 FDA UDI
Model / Reference: 12941001006 FDA UDI
Description: Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 8 Expanded Height (mm): 11 FDA UDI

Identifiers

Primary DI / UDI-DI: B707129410010060 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Metallic spinal interbody fusion cage 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Metallic spinal interbody fusion cage

DUALXS T/PLIF 15 DEG x 8-11MM by Amplify Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Amplify Surgical

Sources (1)

FDA UDI 178a503c-357c-488e-89bd-7e086035677a 34 fields · synced May 30, 2026