ACURA Stabilization System Ø 7.5 x 45 mm Polyaxial Screw - NT

FDA UDI

Class II (US FDA UDI)

by Indius Medical Technologies Private Limited

Identity

Trade Name: ACURA Stabilization System Ø 7.5 x 45 mm Polyaxial Screw - NT FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: ACURA Stabilization System Ø 7.5 x 45 mm Polyaxial Screw - NT FDA UDI
Model / Reference: A004.7445 FDA UDI
Description: ACURA Stabilization System Ø 7.5 x 45 mm Polyaxial Screw - NT FDA UDI

Identifiers

Catalog Number: A004.7445 FDA UDI
Primary DI / UDI-DI: B922A00474450 FDA UDI
FDA Product Code: NKB FDA UDI
KWQ FDA UDI
KWP FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable 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 — 7.5 Millimeter FDA UDI
Length — 45 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

ACURA Stabilization System Ø 7.5 x 45 mm Polyaxial Screw - NT by Indius Medical Technologies Private Limited — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Spinal bone screw, non-bioabsorbable.

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OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
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AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, 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

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Manufacturer

Manufacturer: Indius Medical Technologies Private Limited

Sources (1)

FDA UDI 67f90bb3-2ce2-4de8-8ce7-400be9c7b2f5 36 fields · synced Jun 1, 2026