DUALX PLIF 8 DEG x 9-12MM

GUDID B70712821000005A0

PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Width: 21.1 mm Superior - Inferior Height: 12.5mm Anterior -Posterior Length: 33.4mm

AMPLIFY SURGICAL, INC.

Metallic spinal fusion cage, sterile
Primary Device IDB70712821000005A0
NIH Device Record Key5e741c78-7494-4a63-90f5-41aa70688085
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX PLIF 8 DEG x 9-12MM
Version Model Number12821000005A
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

Phone9492201286
Emailadmin@innovasiveinc.com
Phone9492201286
Emailadmin@innovasiveinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB70712821000005A0 [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 Date2019-05-13
Device Publish Date2019-01-08

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

B70712821000005A0PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Width: 21.1 mm Superior - Inferior Height
B707128210000050PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm):

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