FDA.report

STYLO

Primary DI
B638STT030010
Brand
STYLO
Company
LEGEND SPINE LLC
Model
STT03001
Catalog number
STT03001
Published
2019-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K180071000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K180071000STYLO Interbody Fusion DeviceLegend Spine Technologies2018-05-03MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B638STT030010PrimaryHIBCC0

GMDN Terms

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
Liquid Chemical;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
027460152
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B638STT2209P05120STYLOSTT2209P0512STT2209P05122020-08-31
B638STT2209P05130STYLOSTT2209P0513STT2209P05132020-08-31
B638STT2209P05140STYLOSTT2209P0514STT2209P05142020-08-31
B638STT2209P05150STYLOSTT2209P0515STT2209P05152020-08-31
B638STT2409P05070STYLOSTT2409P0507STT2409P05072020-08-31
B638STT2409P05080STYLOSTT2409P0508STT2409P05082020-08-31

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