3.5mm x 48mm Cortex Screw

GUDID 00814289021362

CONVENTUS ORTHOPAEDICS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00814289021362
NIH Device Record Key1c809f2d-1181-47a8-9d77-438976c2ca7d
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 48mm Cortex Screw
Version Model NumberSC3548
Company DUNS021231299
Company NameCONVENTUS ORTHOPAEDICS, INC.
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814289021362 [Primary]

FDA Product Code

JDSNail, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00814289021362]

Moist Heat or Steam Sterilization


[00814289021362]

Moist Heat or Steam Sterilization


[00814289021362]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-09-22

Devices Manufactured by CONVENTUS ORTHOPAEDICS, INC.

00814289020754 - Conventus Cage - PR, Small2018-07-06
00814289020761 - Conventus Cage - PR, Large2018-07-06
00814289020006 - Conventus Cage - DR, Small2018-03-29
00814289020013 - Conventus Cage - DR, Large2018-03-29
00814289020020 - 2.7mm x 8mm Cannulated Headed Screw2018-03-29
00814289020037 - 2.7mm x 10mm Cannulated Headed Screw2018-03-29
00814289020044 - 2.7mm x 12mm Cannulated Headed Screw2018-03-29
00814289020051 - 2.7mm x 14mm Cannulated Headed Screw2018-03-29

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