DUALX LLIF TRIAL 12-15MM

GUDID B70712835005006A0

12MM X 15MM TRIAL

AMPLIFY SURGICAL, INC.

Spinal implant trial Spinal implant trial
Primary Device IDB70712835005006A0
NIH Device Record Key983ef94b-41e0-4e71-90a9-414d9d977154
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX LLIF TRIAL 12-15MM
Version Model Number12835005006A0
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

Phone7652695439
Emailudi@amplifysurgical.com
Phone7652695439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB70712835005006A0 [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

[B70712835005006A0]

Moist Heat or Steam Sterilization


[B70712835005006A0]

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 LLIF TRIAL 12-15MM]

B70712835005006A012MM X 15MM TRIAL
B707128350050060DUALX LLIF TRIAL 12-15MM
B707128350060060DUALX LLIF TRIAL 12-15MM

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