LOSPA IS Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name: LOSPA IS Spinal Fixation System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Spinal Instrument - MODULAR SET SCREW DRIVER TAPERLOCK FDA UDI
Model / Reference: SI.0P1.0025 FDA UDI
Description: Spinal Instrument - MODULAR SET SCREW DRIVER TAPERLOCK FDA UDI

Identifiers

Primary DI / UDI-DI: 08800017271583 FDA UDI
FDA Product Code: NKB FDA UDI
KWQ FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System by Corentec Co., Ltd — 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: Corentec Co., Ltd

Sources (1)

FDA UDI 45f4dace-c79f-44b0-8663-3f890d684b12 34 fields · synced Jun 6, 2026