FDA.reportPublic FDA data

FORTIFY

Primary DI
00889095616743
Brand
FORTIFY
Company
GLOBUS MEDICAL, INC.
Model
151.333S
Device description
FORTIFY 12mm Upper Endplate, 15x18mm Footprint, 3.5°
Published
2022-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device
PLRSpinal vertebral body replacement device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162315000FORTIFY Corpectomy SpacersGlobus Medical, Inc.2017-11-09MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095616743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095616743008890956167438890956167430889095616743

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14
00193982101909ANTHEM2170.20362170.20362026-08-14
00193982101923ANTHEM2170.20382170.20382026-08-14
00193982101947ANTHEM2170.20402170.20402026-08-14
00193982141097HEDRON1208.0109S1208.0109S2026-08-14
00193982141103HEDRON1208.0111S1208.0111S2026-08-14
00193982141110HEDRON1208.0113S1208.0113S2026-08-14
00193982141127HEDRON1208.0115S1208.0115S2026-08-14
00193982141134HEDRON1208.0117S1208.0117S2026-08-14
00193982141141HEDRON1208.0211S1208.0211S2026-08-14
00193982141158HEDRON1208.0213S1208.0213S2026-08-14
00193982141165HEDRON1208.0215S1208.0215S2026-08-14
00193982141172HEDRON1208.0217S1208.0217S2026-08-14
00193982141189HEDRON1208.0313S1208.0313S2026-08-14
00193982141196HEDRON1208.0315S1208.0315S2026-08-14
00193982141202HEDRON1208.0317S1208.0317S2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857521254ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521261ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521278ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521285ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521292ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521308ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521315ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521322ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521339ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521346ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521353ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521360ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521377ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521384ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521391ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521407ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521414ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521421ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521438ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521445ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521452ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521469ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521476ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521483ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521490ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521506ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521513ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521520ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521537ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26
10888857521544ALEUTIAN® Interbody SystemsVB Spine LLCMQP2021-04-26