Conventus Cage - PR, Large

GUDID 00814289020761

CONVENTUS ORTHOPAEDICS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Primary Device ID00814289020761
NIH Device Record Key5dd78046-2472-48b5-a3b2-723802c67dc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameConventus Cage - PR, Large
Version Model NumberPR-L
Company DUNS021231299
Company NameCONVENTUS ORTHOPAEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Identifiers

Device Issuing AgencyDevice ID
GS100814289020761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

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 Date2015-12-31

Devices Manufactured by CONVENTUS ORTHOPAEDICS, INC.

00814289020754 - Conventus Cage - PR, Small2018-07-06
00814289020761 - Conventus Cage - PR, Large2018-07-06
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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