FDA.reportPublic FDA data

DUALX DUAL PORT CANNULA 60MM

Primary DI
B70712535588004US0
Brand
DUALX DUAL PORT CANNULA 60MM
Company
AMPLIFY SURGICAL, INC.
Model
12535588004US
Device description
60MM 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
B70712535588004US0PrimaryHIBCC0

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
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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