VERTEFIX - MULTI AXIAL PEDICLE SCREW 6.5 X 45 - ELITE SURGICAL SUPPLIES (PTY) LTD

Duns Number:568359710

Device Description: MULTI AXIAL PEDICLE SCREW 6.5 X 45

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More Product Details

Catalog Number

CZ6545CT

Brand Name

VERTEFIX

Version/Model Number

CZ6545CT

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

K080075

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

b9a28272-4d64-4e86-9c2e-c05597685206

Public Version Date

February 03, 2020

Public Version Number

1

DI Record Publish Date

January 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELITE SURGICAL SUPPLIES (PTY) LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 252