FDA.reportPublic FDA data

DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)

Primary DI
B707125355740800
Brand
DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)
Company
AMPLIFY SURGICAL, INC.
Model
12535574080
Device description
INCLUDES:CANNULA 80MMHEMOSTATIC 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
B707125355740800PrimaryHIBCC0

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
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
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)125355731202026-09-04
B70712535005S0Dual X Graft Tamp Short12535005S2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MM129410010132026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MM129410010202026-05-27
B707125355740300DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA)125355740302026-03-05
B707125355740400DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)125355740402026-03-05
B707125355740500DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA)125355740502026-03-05
B707125355740600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)125355740602026-03-05
B707125355740700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)125355740702026-03-05
B707125355740900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)125355740902026-03-05

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