DUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 5.0mm

GUDID B707NHD19050

DOUBLE ENDED DISSECTOR 5.0mm

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable
Primary Device IDB707NHD19050
NIH Device Record Keyf23772ba-6be2-41be-8f74-aed9c497c1cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 5.0mm
Version Model NumberNHD1905
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB707NHD19050 [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

[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


[B707NHD19050]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

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B707125341460550 - DualX LLIF IMPLANT HOLDER 55mm2025-05-21 DUALX LLIF IMPLANT HOLDER 55mm
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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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