FDA.reportPublic FDA data

DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)

Primary DI
B707125355740900
Brand
DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)
Company
AMPLIFY SURGICAL, INC.
Model
12535574090
Device description
INCLUDES:CANNULA 90MMHEMOSTATIC AGENT DELIVERY TUBE
Published
2026-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181397000DualXInnovasive, Inc.2018-09-27MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B707125355740900PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, single-useA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7652675439udi@amplifysurgical.com

Regulatory Flags#

DUNS number
081021000
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7070800118US0DUALX DUAL PORTAL MICRO PITUITARY STRAIGHT 2.0mm0800118US2026-09-28
B7070800218US0DUALX DUAL PORTAL MICRO PITUITARY UP 2.0mm0800218US2026-09-28
B707602003US0DUALX DUAL PORTAL PITUITARY STRAIGHT 2.0mm602003US2026-09-28
B707BHP18042US0DUALX DUAL PORTAL BALL HOOKBHP18042US2026-09-28
B707QU332130US0DUALX DUAL PORTAL CURETTE UP 3.0mmQU332130US2026-09-28
B707UNH2002US0DUALX DUAL PORTAL ROTATORY HANDLEUNH2002US2026-09-28
B707UNH4020US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 2.0mmUNH4020US2026-09-28
B707UNH4030US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 3.0mmUNH4030US2026-09-28
B707USCH2US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR CLAMPUSCH2US2026-09-28
B707USCH3US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR FUSIONUSCH3US2026-09-28
B707USCH1US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR GENERALUSCH1US2025-05-29
B707125355730300DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA)125355730302026-09-04
B707125355730400DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)125355730402026-09-04
B707125355730500DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA)125355730502026-09-04
B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)125355730602026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)125355730702026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)125355730802026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)125355730902026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)125355731002026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)125355731102026-09-04

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