Dsc

FDA UDI

Class II (US FDA UDI)

by Sintea Plustek, LLC

Identity

Trade Name: DSC FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Model / Reference: DSC-12T51 FDA UDI

Identifiers

Primary DI / UDI-DI: 08033726408050 FDA UDI
510(k) Number: K070181 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

MRI Safety

MR Unsafe FDA UDI

Category: Metallic spinal fusion cage, non-sterile

Dsc by Sintea Plustek, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PLIF Cage — Eisertech, LLC · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Copperhead — EMINENT SPINE LLC · Class II
SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II

Cleared under the same submission

K070181 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: Sintea Plustek, LLC

Sources (1)

FDA UDI 5bc1dcb8-412c-46f2-acc1-bfb554c6d5a1 33 fields · synced May 30, 2026