FDA.reportPublic FDA data

DUALXS T/PLIF 15 DEG x 9-12MM

Primary DI
B707129410010130
Brand
DUALXS T/PLIF 15 DEG x 9-12MM
Company
AMPLIFY SURGICAL, INC.
Model
12941001013
Device description
Lordosis & Heights: 15° x 9-12mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 9 Expanded Height (mm): 12
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B707129410010130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
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
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
B70712535588007US0DUALX DUAL PORTAL CANNULA 90MM12535588007US2025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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