VENTO Fixation Screw

GUDID 03701089514354

AMPLITUDE SAS

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID03701089514354
NIH Device Record Key935e905d-6457-404a-beef-22c5b1c302d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENTO Fixation Screw
Version Model Number1-01-12-9140
Company DUNS634855407
Company NameAMPLITUDE SAS
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0033475418741
Emailregulatoryaffairs@amplitude-ortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103701089514354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2017-12-18

On-Brand Devices [VENTO Fixation Screw]

037010895144081-01-12-9170
037010895143921-01-12-9165
037010895143851-01-12-9160
037010895143781-01-12-9155
037010895143611-01-12-9150
037010895143541-01-12-9140
037010895143471-01-12-9135
037010895143301-01-12-9130
037010895143231-01-12-9125
037010895143161-01-12-9120
037010895143091-01-12-9115
037010895010711-01-12-9145

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