DUALX TLIF 8 DEG x 9-12MM

GUDID B707125310060040

PLEASE DELETE

AMPLIFY SURGICAL, INC.

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Primary Device IDB707125310060040
NIH Device Record Key45bb31e0-ef82-4a37-b66e-090099c5830f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX TLIF 8 DEG x 9-12MM
Version Model Number12531006004
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
HIBCCB707125310060040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-16
Device Publish Date2019-07-22

On-Brand Devices [DUALX TLIF 8 DEG x 9-12MM]

B70712531006005B0TLIF IMPLANT - Revision B Lordosis & Heights: 8° x 9-12mm Lateral Length/Width: 21.1 mm Superio
B70712531006005A0TLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Length/Width: 21.1 mm Superior - Inferior
B707125310060050TLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm):
B707125310060040PLEASE DELETE

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