Catalog Number

-

Brand Name

CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 8mm

Version/Model Number

8114-008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K050241,K080590,K090478

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

1d18b1bc-a6e0-49ef-99bc-3095606aab5d

Public Version Date

June 24, 2020

Public Version Number

3

DI Record Publish Date

May 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-