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: Polymeric spinal interbody fusion cage FDA UDI
Device Name: PEEK Clip, Size 12x17x4 mm FDA UDI
Model / Reference: 1703-C0004 FDA UDI
Description: PEEK Clip, Size 12x17x4 mm FDA UDI

Identifiers

Catalog Number: 1703-C0004 FDA UDI
Primary DI / UDI-DI: 10888857022836 FDA UDI
FDA Product Code: MQP FDA UDI
PLR FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage 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: Length — 12 Millimeter FDA UDI
Width — 17 Millimeter FDA UDI
Height — 4 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage

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

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, 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 fadba595-f3d5-4030-9a54-311d78b7fb27 36 fields · synced May 31, 2026