CoFix Implant 12 mm - Paradigm Spine GmbH

Duns Number:537619731

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More Product Details

Catalog Number

RQI00012

Brand Name

CoFix Implant 12 mm

Version/Model Number

RQI00012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K153302

Product Code Details

Product Code

PEK

Product Code Name

Spinous Process Plate

Device Record Status

Public Device Record Key

7e373cf6-5991-4156-ad0c-4742b01cb592

Public Version Date

June 10, 2021

Public Version Number

3

DI Record Publish Date

March 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARADIGM SPINE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 191
2 A medical device with a moderate to high risk that requires special controls. 301
3 A medical device with high risk that requires premarket approval 49