DUALXS T/PLIF 8 DEG x 7-9MM

GUDID B707129410010030

Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm): 9

Amplify Surgical, Inc.

Metallic spinal interbody fusion cage
Primary Device IDB707129410010030
NIH Device Record Keyd9991bd4-2fc6-4673-ab2c-961b974fdefa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALXS T/PLIF 8 DEG x 7-9MM
Version Model Number12941001003
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
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707129410010030 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


[B707129410010030]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-17
Device Publish Date2023-07-07

On-Brand Devices [DUALXS T/PLIF 8 DEG x 7-9MM]

B707129410010030Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Heigh
B707129410010040Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Heigh

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