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: Open-surgery dissector FDA UDI
Device Name: Dissector, Tissue, MIS FDA UDI
Model / Reference: 10-K01-9250 FDA UDI
Description: Dissector, Tissue, MIS FDA UDI

Identifiers

Primary DI / UDI-DI: B07310K0192500 FDA UDI
FDA Product Code: GDI FDA UDI
GMDN Term: Open-surgery dissector 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

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: Open-surgery dissector

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 Open-surgery dissector.

Kamiyama — TAKAYAMA INSTRUMENTS INC. · Class I
KEYSTONE — Depuy Spine, Inc. · Class I
Life Instruments — Life Instrument Corporation · Class I
Wiggins Medical — EBNER MEDICAL LLC · Class I
Fisch dissector — Spiggle & Theis Medizintechnik GmbH · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kalitec Direct LLC

Sources (1)

FDA UDI dc9b0616-54e9-4f66-bf92-f1590df1887f 33 fields · synced May 30, 2026