SANTORINI™ Corpectomy Cage System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: SANTORINI™ Corpectomy Cage System FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: Lateral Expandable Cage -Clip FDA UDI
Model / Reference: 1703-C0620L FDA UDI
Description: Lateral Expandable Cage -Clip FDA UDI

Identifiers

Catalog Number: 1703-C0620L FDA UDI
Primary DI / UDI-DI: 10888857023031 FDA UDI
FDA Product Code: MQP 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 20 Millimeter FDA UDI
Height — 6 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI

Category: Vertebral body prosthesis

SANTORINI™ Corpectomy Cage System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis.

FORTIFY — GLOBUS MEDICAL, INC. · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Novel — ALPHATEC SPINE, INC. · Class II
Regatta — SeaSpine Orthopedics Corporation · Class II
C-THRU™ Anterior Spinal System — BIOMET SPINE LLC · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Novel — ALPHATEC SPINE, INC. · Class II
XPAND-R — GLOBUS MEDICAL, INC. · Class II

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: K2m, Inc.

Sources (1)

FDA UDI 7b0b0e8e-1aaa-4510-8cd3-376f1b31778c 36 fields · synced May 31, 2026