Proficient® Posterior Cervical Spine System

FDA UDI

Class II (US FDA UDI)

by Spine Wave, Inc.

Identity

Trade Name: Proficient® Posterior Cervical Spine System FDA UDI
Generic Name: Spinal bone set screw FDA UDI
Device Name: Connector Locking Screw, 2.5 mm Hex FDA UDI
Model / Reference: 11-9231 FDA UDI
Description: Connector Locking Screw, 2.5 mm Hex FDA UDI

Identifiers

Catalog Number: 11-9231 FDA UDI
Primary DI / UDI-DI: 10840642121216 FDA UDI
FDA Product Code: NKG FDA UDI
GMDN Term: Spinal bone set screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Spinal bone set screw

Proficient® Posterior Cervical Spine System by Spine Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SET SCREW — OsteoCentric Technologies,Inc · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · 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 II	Pending data

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Manufacturer

Manufacturer: Spine Wave, Inc.

Sources (1)

FDA UDI c88ea8b2-bba1-4310-8187-e3cf8ffa51d5 35 fields · synced May 30, 2026