DUALX TUBE RETRACTOR 18 X 150MM

GUDID B7071253560011500

18 X 150MM

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB7071253560011500
NIH Device Record Key9413e36b-f939-45be-a8d2-800c92be4317
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX TUBE RETRACTOR 18 X 150MM
Version Model Number125356001150
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
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
HIBCCB7071253560011500 [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

[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


[B7071253560011500]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-18
Device Publish Date2023-08-10

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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