Twin Peaks

FDA UDI

Class II (US FDA UDI)

by Spineway SA

Identity

Trade Name: TWIN PEAKS FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Device Name: Lumbar cage for TLIF H7/L35/4° FDA UDI
Model / Reference: 1 FDA UDI
Description: Lumbar cage for TLIF H7/L35/4° FDA UDI

Identifiers

Catalog Number: TP1T7354 FDA UDI
Primary DI / UDI-DI: 03663422050854 FDA UDI
510(k) Number: K152355 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric spinal fusion cage, sterile 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 35 Millimeter FDA UDI
Height — 7 Millimeter FDA UDI
Angle — 4 degree FDA UDI

Category: Polymeric spinal fusion cage, sterile

Twin Peaks by Spineway SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal fusion cage, sterile.

TALOS® IBF — MEDITECH SPINE, LLC · Class II
ROCCIA — Silony Medical GmbH · Class II
TiNano — AURORA SPINE, INC. · Class II
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
Aurora Spine — AURORA SPINE, INC. · Class II
TALOS®-C — MEDITECH SPINE, LLC · Class II
Avenue T — Ldr Spine USA · Class II
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II

Cleared under the same submission

K152355 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: Spineway SA

Sources (1)

FDA UDI 41473261-4589-407a-ba8d-432a3d98082d 37 fields · synced Jun 6, 2026