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LOSPA IS Spinal System

FDA UDI

Class I (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name
LOSPA IS Spinal System FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Guide Breaker FDA UDI
Model / Reference
SI.AP6.0057 FDA UDI
Description
Guide Breaker FDA UDI

Identifiers

Primary DI / UDI-DI
08800068962638 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

LOSPA IS Spinal System by Corentec Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corentec Co., Ltd

Sources (1)

  • FDA UDI 66497732-f68a-4592-a669-96206eab978c 34 fields · synced Jun 1, 2026