DUALX TLIF TRIAL 12-15MM

GUDID B70712535200006A0

DUALX TLIF TRIAL 12-15MM

AMPLIFY SURGICAL, INC.

Spinal implant trial
Primary Device IDB70712535200006A0
NIH Device Record Key44b0e50e-e3e7-41b0-9a17-17ce81455946
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX TLIF TRIAL 12-15MM
Version Model Number12535200006A0
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

Phone949-220-1286
Emailadmin@innovasiveinc.com
Phone949-220-1286
Emailadmin@innovasiveinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB70712535200006A0 [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

[B70712535200006A0]

Moist Heat or Steam Sterilization


[B70712535200006A0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-13
Device Publish Date2019-01-08

On-Brand Devices [DUALX TLIF TRIAL 12-15MM ]

B70712535200006A0DUALX TLIF TRIAL 12-15MM
B707125352000060DUALX TLIF TRIAL 12-15MM Rev D

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