FDA.reportPublic FDA data

DUALX DUAL PORT OSTEOTOME 15 CVD 4.0MM

Primary DI
B707UOT1752410050
Brand
DUALX DUAL PORT OSTEOTOME 15 CVD 4.0MM
Company
AMPLIFY SURGICAL, INC.
Model
UOT175241005
Device description
4.0MM15 DEG
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
B707UOT1752410050PrimaryHIBCC0

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
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
B70712535588006US0DUALX DUAL PORTAL CANNULA 80MM12535588006US2025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02