ACURA Stabilization System

FDA UDI

Class II (US FDA UDI)

by Indius Medical Technologies Private Limited

Identity

Trade Name: ACURA Stabilization System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: ACURA Stabilization System 5.5 mm x 120 mm TAV Curved Rod FDA UDI
Model / Reference: A004.2120 FDA UDI
Description: ACURA Stabilization System 5.5 mm x 120 mm TAV Curved Rod FDA UDI

Identifiers

Catalog Number: A004.2120 FDA UDI
Primary DI / UDI-DI: B922A00421200 FDA UDI
FDA Product Code: NKB FDA UDI
KWQ FDA UDI
KWP FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3060 FDA UDI
888.3050 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

Dimensions & Sizes

Size: Outer Diameter — 5.5 Millimeter FDA UDI
Length — 120 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

ACURA Stabilization System by Indius Medical Technologies Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · 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

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

Manufacturer

Manufacturer: Indius Medical Technologies Private Limited

Sources (1)

FDA UDI 9c4ae9e2-9e4b-4680-a986-2111299f9df6 36 fields · synced May 31, 2026