Ø6.5mm x 35mm Pedicle Micro Reduction Screw with Set Screw Package - Update: SETX Ø6.5mm x 35mm Cannulated Micro - XENCO MEDICAL LLC

Duns Number:079282130

Device Description: Update: SETX Ø6.5mm x 35mm Cannulated Micro Extended Pedicle Screw with Set Screw

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More Product Details

Catalog Number

-

Brand Name

Ø6.5mm x 35mm Pedicle Micro Reduction Screw with Set Screw Package

Version/Model Number

XM-225-6535

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

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

8897ecbc-a640-45bb-bef5-b9501c745c60

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 03, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XENCO MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 190