DUALX TLIF TRIAL 8-11MM

GUDID B707125352000020

DUALX TLIF TRIAL 8-11MM Rev D

AMPLIFY SURGICAL, INC.

Spinal implant trial
Primary Device IDB707125352000020
NIH Device Record Key49e7637e-5edb-4939-8f03-76b08369a964
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX TLIF TRIAL 8-11MM
Version Model Number12535200002
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
HIBCCB707125352000020 [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

[B707125352000020]

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 8-11MM]

B70712535200002A0DUALX TLIF TRIAL 8-11MM
B707125352000020DUALX TLIF TRIAL 8-11MM Rev D
B707125354000030DUALX TLIF TRIAL 8-11MM
B707125354010030DUALX TLIF TRIAL 8-11MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.