Lospa Modular Knee System

FDA UDI

Class I (US FDA UDI)

by Corentec Co., Ltd

Identity

Trade Name: Lospa Modular Knee System FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: Femoral AP Cutting Guide #07 FDA UDI
Model / Reference: KB.SFC.E007 FDA UDI
Description: Femoral AP Cutting Guide #07 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800068972316 FDA UDI
FDA Product Code: HTZ FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Osteotomy guide, reusable

The Lospa Modular Knee System is a cutting guide designed to help orthopedic surgeons outline and define the desired cut-line during osteotomy procedures, providing precise guidance and support for mechanical osteotomy.

Similar devices

Also classified as Osteotomy guide, reusable.

Legion — Smith & Nephew, Inc. · Class II
MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
Persona® — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Profix — Smith & Nephew, Inc. · Class II
QUANTUM — IN2BONES · Class I
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Corentec Co., Ltd

Sources (1)

FDA UDI 784019a2-e959-4aad-a5a5-fccf011203e6 34 fields · synced Jul 22, 2026