DUALX LLIF 10-13MM x 12 DEG x 40MM

GUDID B707128310000060

LLIF IMPLANT - 12° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 12° x 40mm Collapsed Width (mm): 13.34 Expanded Width (mm): 22 Collapsed Height (mm): 10.5 Expanded Height (mm): 13.5 Collapsed Length (mm): 48.76 Expanded Length (mm): 41.8

Amplify Surgical, Inc.

Metallic spinal interbody fusion cage
Primary Device IDB707128310000060
NIH Device Record Key0c43c843-db9f-44ce-9cef-963e899e7866
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX LLIF 10-13MM x 12 DEG x 40MM
Version Model Number12831000006
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
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
Phone7652675439
Emailudi@amplifysurgical.com
Phone7652675439
Emailudi@amplifysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707128310000060 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-05
Device Publish Date2025-04-25

Devices Manufactured by Amplify Surgical, Inc.

B707125341260 - dualX Graft Delivery Tip (USA)2025-05-21 DUALX Graft Delivery Tip
B70712534146040 - DualX LLIF IMPLANT HOLDER 40mm2025-05-21 DUALX LLIF IMPLANT HOLDER 40mm
B707125341460450 - DualX LLIF IMPLANT HOLDER 45mm2025-05-21 DUALX LLIF IMPLANT HOLDER 45mm
B707125341460550 - DualX LLIF IMPLANT HOLDER 55mm2025-05-21 DUALX LLIF IMPLANT HOLDER 55mm
B707128400060010 - DUALXS T/PLIF LOCKOUT SCREW SHORT2025-05-21 DUALXS T/PLIF LOCKOUT SCREW SHORT
B707128450070 - DUALX LLIF IMPLANT STERILIZATION CADDY2025-05-21 LLIF IMPLANT STERILIZATION CADDY
B707129410010010 - DUALXS T/PLIF 12 DEG x 7-10MM2025-05-21 Lordosis & Heights: 12° x 7-10mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm)
B707128300090010 - DUALX LLIF LOCKOUT SCREW 2 X 40MM2025-05-08 DUALX LLIF LOCKOUT SCREW 2 X 40MM

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