KIT DUALX PLIF 0 DEG x 7-9MM

GUDID B707128230000010

Lordosis & Heights: 0° x 7-9mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed Height (mm): 6.21 Expanded Height (mm): 9.5 Collapsed Length (mm): 39.69 Expanded Length (mm): 33.4 PLIF SCREW

AMPLIFY SURGICAL, INC.

Metallic spinal interbody fusion cage
Primary Device IDB707128230000010
NIH Device Record Key11103cae-1417-44d5-8d02-82befbd1082e
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIT DUALX PLIF 0 DEG x 7-9MM
Version Model Number12823000001
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

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
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707128230000010 [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 Number4
Public Version Date2020-02-24
Device Publish Date2019-05-09

On-Brand Devices [KIT DUALX PLIF 0 DEG x 7-9MM]

B70712823000001A0Lordosis & Heights: 0° x 7-9mm Lateral Width: 21.1 mm Superior - Inferior Height: 9.5mm Anteri
B707128230000010Lordosis & Heights: 0° x 7-9mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed
B707128220000010Lordosis & Heights: 0° x 7-9mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed

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