FDA.reportPublic FDA data

Spine Innovation Interbody System

Primary DI
00817722020427
Brand
Spine Innovation Interbody System
Company
SPINE INNOVATION, LLC
Model
90-SDA-283012
Device description
Expandable Implant 10° x 8mm W x 12mm 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
00817722020427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817722020427008177220204278177220204270817722020427

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
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14
07613153046431AVS TLStryker CorporationMAX2015-09-14
07613153046448AVS TLStryker CorporationMAX2015-09-14
07613153046455AVS TLStryker CorporationMAX2015-09-14
07613153046462AVS TLStryker CorporationMAX2015-09-14
07613153046479AVS TLStryker CorporationMAX2015-09-14
07613153046486AVS TLStryker CorporationMAX2015-09-14
07613153046493AVS TLStryker CorporationMAX2015-09-14
07613153046509AVS TLStryker CorporationMAX2015-09-14
07613153046530AVS TLStryker CorporationMAX2015-09-14
07613153046547AVS TLStryker CorporationMAX2015-09-14
07613153046578AVS TLStryker CorporationMAX2015-09-14
07613153046592AVS TLStryker CorporationMAX2015-09-14
07613153046622AVS TLStryker CorporationMAX2015-09-14
07613153046639AVS TLStryker CorporationMAX2015-09-14
07613153046646AVS TLStryker CorporationMAX2015-09-14
07613153046677AVS TLStryker CorporationMAX2015-09-14
07613153046684AVS TLStryker CorporationMAX2015-09-14