DUALX TLIF TRIAL 7-9MM

GUDID B707125352000010

DUALX TLIF TRIAL 7-9MM Rev D

AMPLIFY SURGICAL, INC.

Spinal implant trial
Primary Device IDB707125352000010
NIH Device Record Key1aab920f-0115-446b-b5de-7469c15d49d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX TLIF TRIAL 7-9MM
Version Model Number12535200001
Company DUNS081021000
Company NameAMPLIFY SURGICAL, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707125352000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B707125352000010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-31
Device Publish Date2019-05-23

On-Brand Devices [DUALX TLIF TRIAL 7-9MM]

B70712535200001A0DUALX TLIF TRIAL 7-9MM
B707125352000010DUALX TLIF TRIAL 7-9MM Rev D
B707125354000090DUALX TLIF TRIAL 7-9MM
B707125354010090DUALX TLIF TRIAL 7-9MM

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