FDA.reportPublic FDA data

FORZA XP

Primary DI
18257200155804
Brand
FORZA XP
Company
Orthofix US LLC
Model
28-2140SP
Device description
6.5mm X 10mm WIDE X 24mm NON-LORDOTIC ASSEMBLY, STERILE
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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
K213951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213951000FORZA XP Expandable Spacer SystemOrthofix US, LLC2022-01-05MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200155804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720015580418257200155804

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200115112Collage7100052016-03-02
18257200115129Collage7100102016-03-02
18257200115136Collage7100152016-03-02
18257200121861Collage7110102016-09-14
18257200121878Collage7110152016-09-14
18257200028177PHOENIX SFS20-01012026-07-17
18257200028207PHOENIX SFS20-01202026-07-17
18257200028917FIREBIRD SFS201130732026-07-17
18257200028924FIREBIRD SFS201130742026-07-17
18257200028931FIREBIRD SFS201130752026-07-17
18257200028948FIREBIRD SFS201130762026-07-17
18257200028955FIREBIRD SFS201130782026-07-17
18257200028979FIREBIRD SFS201130802026-07-17
18257200028986FIREBIRD SFS201130812026-07-17
18257200028993FIREBIRD SFS201130822026-07-17
18257200029006FIREBIRD SFS201130832026-07-17
18257200029013FIREBIRD SFS201130842026-07-17
18257200029020FIREBIRD SFS201130852026-07-17
18257200029280FIREBIRD SFS201147972026-07-17
18257200029846FIREBIRD SFS301100252026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916245SABER-XA, Expandable Spacer, 40x30mm, 11mm, (6°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916269SABER-XA, Expandable Spacer, 40x30mm, 16mm, (18°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
07640139342287Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19