ACURA Stabilization System 8.5 mm x 30 mm Polyaxial Screw - ACURA Stabilization System 8.5 mm x 30 mm - INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Duns Number:860396609

Device Description: ACURA Stabilization System 8.5 mm x 30 mm Polyaxial Screw

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

A004.0530

Brand Name

ACURA Stabilization System 8.5 mm x 30 mm Polyaxial Screw

Version/Model Number

A004.0530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

bbdb61a9-422c-4274-8d28-89aff3335ca2

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 55
2 A medical device with a moderate to high risk that requires special controls. 124