DUALX ACME PIN

GUDID B707125342180

DUALX ACME PIN

Amplify Surgical, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device IDB707125342180
NIH Device Record Key9ce57288-b945-4bc1-92b3-2085a54c63c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX ACME PIN
Version Model Number12534218
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707125342180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


[B707125342180]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2021-09-01

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.