3.5mm x 48mm Cannulated Headed Screw

GUDID 00814289020617

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 ID00814289020617
NIH Device Record Key06a6c45b-e8c7-4bc2-bf78-412c21bd098b
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 48mm Cannulated Headed Screw
Version Model NumberCH3548
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
GS100814289020617 [Primary]

FDA Product Code

JDSNail, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00814289020617]

Moist Heat or Steam Sterilization


[00814289020617]

Moist Heat or Steam Sterilization


[00814289020617]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-18

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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