FDA.reportPublic FDA data

Spine Innovation Interbody System

Primary DI
00817722020342
Brand
Spine Innovation Interbody System
Company
SPINE INNOVATION, LLC
Model
90-SDA-113013
Device description
Expandable Implant 5° x 11mm W x 13mm H x 30mm L
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K153356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153356000Spine Innovation Interbody SystemSpine Innovation, LLC2016-01-14MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817722020342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817722020342008177220203428177220203420817722020342

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080376573
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817722020007Spine Innovation Interbody System90-SDA-0826082017-02-15
00817722020014Spine Innovation Interbody System90-SDA-0830082017-02-15
00817722020021Spine Innovation Interbody System90-SDA-0826092017-02-15
00817722020038Spine Innovation Interbody System90-SDA-0830092017-02-15
00817722020045Spine Innovation Interbody System90-SDA-0826102017-02-15
00817722020052Spine Innovation Interbody System90-SDA-0830102017-02-15
00817722020069Spine Innovation Interbody System90-SDA-0826162017-02-15
00817722020076Spine Innovation Interbody System90-SDA-0926102017-02-15
00817722020083Spine Innovation Interbody System90-SDA-0930102017-02-15
00817722020090Spine Innovation Interbody System90-SDA-0926112017-02-15
00817722020106Spine Innovation Interbody System90-SDA-0930112017-02-15
00817722020113Spine Innovation Interbody System90-SDA-0026112017-02-15
00817722020120Spine Innovation Interbody System90-SDA-0030112017-02-15
00817722020137Spine Innovation Interbody System90-SDA-0026122017-02-15
00817722020144Spine Innovation Interbody System90-SDA-0030122017-02-15
00817722020151Spine Innovation Interbody System90-SDA-0126122017-02-15
00817722020168Spine Innovation Interbody System90-SDA-0130122017-02-15
00817722020175Spine Innovation Interbody System90-SDA-0126132017-02-15
00817722020182Spine Innovation Interbody System90-SDA-0130132017-02-15
00817722020199Spine Innovation Interbody System90-SDA-0226132017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14