FDA.reportPublic FDA data

DUALX DUAL PORTAL 2.0 ANGLE GUIDE SIZE 1, BETA

Primary DI
B707125450400010
Brand
DUALX DUAL PORTAL 2.0 ANGLE GUIDE SIZE 1, BETA
Company
AMPLIFY SURGICAL, INC.
Model
12545040001
Device description
DUAL PORTAL 2.0 ANGLE GUIDE SIZE 1, BETA
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B707125450400010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, reusableA non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

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
No natural rubber latex
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
B707125355740800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)125355740802026-03-05

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