FDA.reportPublic FDA data

STYLO

Primary DI
B638STT025130
Brand
STYLO
Company
LEGEND SPINE LLC
Model
STT02513
Catalog number
STT02513
Published
2019-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K180071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180071000STYLO Interbody Fusion DeviceLegend Spine Technologies2018-05-03MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B638STT025130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-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) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Liquid Chemical""]"
Moist Heat or Steam Sterilization;Liquid Chemical

Regulatory Flags#

DUNS number
027460152
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B638CN1714P06040CorniceCN1714P0604CN1714P06042020-10-16
B638CN1714P06050CorniceCN1714P0605CN1714P06052020-10-16
B638CN1714P06060CorniceCN1714P0606CN1714P06062020-10-16
B638CN1714P06070CorniceCN1714P0607CN1714P06072020-10-16
B638CN1714P06080CorniceCN1714P0608CN1714P06082020-10-16
B638CN1714P06090CorniceCN1714P0609CN1714P06092020-10-16
B638CN1714P06100CorniceCN1714P0610CN1714P06102020-10-16
B638CN1714P06110CorniceCN1714P0611CN1714P06112020-10-16
B638CN1714P06120CorniceCN1714P0612CN1714P06122020-10-16
B638STT2209P05070STYLOSTT2209P0507STT2209P05072020-08-31
B638STT2209P05080STYLOSTT2209P0508STT2209P05082020-08-31
B638STT2209P05090STYLOSTT2209P0509STT2209P05092020-08-31
B638STT2209P05100STYLOSTT2209P0510STT2209P05102020-08-31
B638STT2209P05110STYLOSTT2209P0511STT2209P05112020-08-31
B638STT2209P05120STYLOSTT2209P0512STT2209P05122020-08-31
B638STT2209P05130STYLOSTT2209P0513STT2209P05132020-08-31
B638STT2209P05140STYLOSTT2209P0514STT2209P05142020-08-31
B638STT2209P05150STYLOSTT2209P0515STT2209P05152020-08-31
B638STT2409P05070STYLOSTT2409P0507STT2409P05072020-08-31
B638STT2409P05080STYLOSTT2409P0508STT2409P05082020-08-31

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