FDA.reportPublic FDA data

DUALX DUAL PORT OSTEOTOME STRAIGHT 4.0MM

Primary DI
B707UOT1202410010
Brand
DUALX DUAL PORT OSTEOTOME STRAIGHT 4.0MM
Company
AMPLIFY SURGICAL, INC.
Model
UOT120241001
Device description
4.0MM
Published
2026-02-05
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
B707UOT1202410010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
No natural rubber latex
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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Primary DI, Brand, Company table
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B707QU332130US0DUALX DUAL PORTAL CURETTE UP 3.0mmAMPLIFY SURGICAL, INC.MAX2026-09-28
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B707UNH4020US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 2.0mmAMPLIFY SURGICAL, INC.MAX2026-09-28
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