FDA.reportPublic FDA data

DUALX DUAL PORTAL CANNULA 80MM

Primary DI
B70712535588006US0
Brand
DUALX DUAL PORTAL CANNULA 80MM
Company
AMPLIFY SURGICAL, INC.
Model
12535588006US
Device description
80MM US MANUFACTURE
Published
2025-05-29
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
B70712535588006US0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

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
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
B707125355741000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)125355741002026-03-05
B707125355741100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)125355741102026-03-05
B707125355741200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)125355741202026-03-05
B707125355860DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA)125355862025-05-29
B70712535588001US0DUALX DUAL PORT CANNULA 30MM12535588001US2025-05-29
B70712535588002US0DUALX DUAL PORT CANNULA 40MM12535588002US2025-05-29
B70712535588003US0DUALX DUAL PORT CANNULA 50MM12535588003US2025-05-29
B70712535588004US0DUALX DUAL PORT CANNULA 60MM12535588004US2025-05-29
B70712535588005US0DUALX DUAL PORT CANNULA 70MM12535588005US2025-05-29
B70712535588007US0DUALX DUAL PORTAL CANNULA 90MM12535588007US2025-05-29

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