DUALX TLIF TRIAL 11-14MM

GUDID B707125354010060

DUALX TLIF TRIAL 11-14MM

AMPLIFY SURGICAL, INC.

Spinal implant trial
Primary Device IDB707125354010060
NIH Device Record Key2cb25918-7f77-4226-a492-50126be26d40
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX TLIF TRIAL 11-14MM
Version Model Number12535401006
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
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707125354010060 [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

[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


[B707125354010060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-12
Device Publish Date2020-10-02

On-Brand Devices [DUALX TLIF TRIAL 11-14MM]

B70712535200005A0DUALX TLIF TRIAL 11-14MM
B707125352000050DUALX TLIF TRIAL 11-14MM Rev D
B707125354000060DUALX TLIF TRIAL 11-14MM
B707125354010060DUALX TLIF TRIAL 11-14MM

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