FDA.reportPublic FDA data

DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)

Primary DI
B707125355730400
Brand
DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)
Company
AMPLIFY SURGICAL, INC.
Model
12535573040
Device description
INCLUDES: CANNULA 40MM HEMOSTATIC AGENT DELIVERY TUBE
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
B707125355730400PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
B707125355740800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)125355740802026-03-05
B707125355740900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)125355740902026-03-05

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