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: Bone access cannula FDA UDI
Device Name: Needle, Trocar Stylet, Stainless Steel, Disposable FDA UDI
Model / Reference: 10-K01-1530 FDA UDI
Description: Needle, Trocar Stylet, Stainless Steel, Disposable FDA UDI

Identifiers

Primary DI / UDI-DI: B07310K0115300 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Bone access cannula 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

Yes

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: Bone access cannula

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 Bone access cannula.

BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — Tecres · Class I
Arthrex® — Arthrex, Inc. · Class I
Stryker — Provision · Class I
Omnia Medical PsiF — Omnia Medical · Class I
Arthrex® — Arthrex, Inc. · Class I
Omnia Medical Instruments — Omnia Medical · Class I
Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II

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 f6445370-0ea5-4ef9-8093-25f7d71a4624 33 fields · synced May 31, 2026