CarboClear Pedicle Screw System - Patient-Specific Curved Rod (oncology) of the - CARBOFIX ORTHOPEDICS LTD

Duns Number:649185170

Device Description: Patient-Specific Curved Rod (oncology) of the CarboClear Pedicle Screw System

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More Product Details

Catalog Number

SP0001

Brand Name

CarboClear Pedicle Screw System

Version/Model Number

Patient Specific Curved Rod

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K173487

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

efcffb6a-d060-41c5-af9f-2e7dd1752b12

Public Version Date

May 26, 2021

Public Version Number

1

DI Record Publish Date

May 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARBOFIX ORTHOPEDICS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1387