605014S

GUDID 07613327350005

Cortex Screw S.T.

Stryker Trauma SA

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID07613327350005
NIH Device Record Keyc90c441e-7227-4f40-9570-7838bee8848f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number605014S
Catalog Number605014S
Company DUNS481999654
Company NameStryker Trauma SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0
Length14 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327350005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-05

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