Matira Anterior Cervical System

FDA UDI

Class I (US FDA UDI)

by Kalitec Direct LLC

Identity

Trade Name: MATIRA ANTERIOR CERVICAL SYSTEM FDA UDI
Generic Name: Intraoperative bone pin/screw, non-sterile FDA UDI
Device Name: Temporary Pin, BMA Disposable FDA UDI
Model / Reference: 07-APD-1020 FDA UDI
Description: Temporary Pin, BMA Disposable FDA UDI

Identifiers

Primary DI / UDI-DI: B07307APD10200 FDA UDI
FDA Product Code: GCZ FDA UDI
GMDN Term: Intraoperative bone pin/screw, non-sterile 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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: Intraoperative bone pin/screw, non-sterile

Matira Anterior Cervical System by Kalitec Direct LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Vantage — Exactech, Inc. · Class I
Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
ADVANCE® — MicroPort Orthopedics Inc. · 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 1ab4ec94-c2f6-4f14-936e-0609cda62258 33 fields · synced May 30, 2026