CosmoLock Pedicle Screw System

FDA UDI

Class I (US FDA UDI)

by Kalitec Direct LLC

Identity

Trade Name: CosmoLock Pedicle Screw System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: T-Handle, T30 Split Tip Cap Starter, MIS FDA UDI
Model / Reference: 10-K01-4020 FDA UDI
Description: T-Handle, T30 Split Tip Cap Starter, MIS FDA UDI

Identifiers

Primary DI / UDI-DI: B07310K0140200 FDA UDI
FDA Product Code: HWD FDA UDI
GMDN Term: Surgical screwdriver, 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

FDA UDI

Single Use

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

Category: Surgical screwdriver, reusable

CosmoLock Pedicle Screw System by Kalitec Direct LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical screwdriver, reusable.

Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
PERLA ® TL — Spineart · Class II
USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
KLOCKNER — SOADCO, S.L. · 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: Kalitec Direct LLC

Sources (1)

FDA UDI e9cc8e99-88f1-48bb-b8a7-7940366f9ef2 33 fields · synced May 30, 2026