FDA.reportPublic FDA data

STYLO

Primary DI
B638STT1110020
Brand
STYLO
Company
LEGEND SPINE LLC
Model
STT111002
Catalog number
STT111002
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
B638STT1110020PrimaryHIBCC0

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

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