KIT DUALX LLIF 7-9MM x 0 DEG x 55MM

GUDID B70712833005004A0

LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 55mm Lateral Width: 56.8mm Superior - Inferior Height: 9.5mm Anterior -Posterior Width: 22mm LLIF SCREW - 55MM

AMPLIFY SURGICAL, INC.

Metallic spinal fusion cage, sterile Metallic spinal fusion cage, sterile
Primary Device IDB70712833005004A0
NIH Device Record Key9a978679-b174-4b55-99d6-6efac9b8b5d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIT DUALX LLIF 7-9MM x 0 DEG x 55MM
Version Model Number12833005004A
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
Phone949-220-1286
Emailadmin@innovasiveinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB70712833005004A0 [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 [KIT DUALX LLIF 7-9MM x 0 DEG x 55MM]

B70712833005004A0LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 55mm Lateral Width: 56.8mm
B707128330050040LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 55mm Collapsed Width (mm):
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