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LOSPA IS Spinal System

FDA UDI

Class II (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name
LOSPA IS Spinal System FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
ALIF TRIAL 6° 24 X 30 X 9 FDA UDI
Model / Reference
SI.C20.0109 FDA UDI
Description
ALIF TRIAL 6° 24 X 30 X 9 FDA UDI

Identifiers

Primary DI / UDI-DI
08800017284842 FDA UDI
510(k) Number
K151408 FDA UDI
FDA Product Code
MAX FDA UDI
ODP FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

No

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: Spinal implant trial

The LOSPA IS Spinal System is a high-quality, intervertebral fusion device with bone graft used in spinal surgery. This device has been designed to provide stable and durable fixation of the spine, while also allowing for easy implantation and removal. The LOSPA IS Spinal System is available for use by licensed medical professionals in various countries around the world.

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K151408 also covers:

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 675f4066-be2a-4ef3-b361-e031e580d56b 35 fields · synced Jul 30, 2026