FDA.reportPublic FDA data

Skye Cervical Plate System

Primary DI
00195860010099
Brand
Skye Cervical Plate System
Company
Evolution Spine LLC
Model
CP653
Catalog number
CP653
Device description
65mm 3 Level Plate
Published
2021-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173375000Anterior Cervical Plate SystemEvolution Spine, LLC2017-12-21KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195860010099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195860010099001958600100991958600100990195860010099

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length65Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)682-8536info@evolutionspine.com

Regulatory Flags#

DUNS number
116940934
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195860023112EMERGE Anterior Cervical Plate System100-A068100-A0682023-08-21
00195860014042EMERGE Anterior Cervical Plate System100-A024100-A0242021-11-01
00195860014059EMERGE Anterior Cervical Plate System100-A025100-A0252021-11-01
00195860010457Skye Cervical Plate SystemCP-1007CP-10072021-06-02
00195860031803E3D-C Interbody System130-A129130-A1292026-02-20
00195860031810E3D-C Interbody System130-A130130-A1302026-02-20
00195860031827E3D-C Interbody System130-A131130-A1312026-02-20
00195860031834E3D-C Interbody System130-A132130-A1322026-02-20
00195860031841E3D-C Interbody System130-A133130-A1332026-02-20
00195860031858E3D-C Interbody System130-A134130-A1342026-02-20
00195860031865E3D-C Interbody System130-A135130-A1352026-02-20
00195860031872E3D-C Interbody System130-A136130-A1362026-02-20
00195860031889E3D-C Interbody System130-A137130-A1372026-02-20
00195860031896E3D-C Interbody System130-A138130-A1382026-02-20
00195860031902E3D-C Interbody System130-A139130-A1392026-02-20
00195860031919E3D-C Interbody System130-A140130-A1402026-02-20
00195860031926E3D-C Interbody System130-A141130-A1412026-02-20
00195860031933E3D-C Interbody System130-A142130-A1422026-02-20
00195860031940E3D-C Interbody System130-A143130-A1432026-02-20
00195860031957E3D-C Interbody System130-A144130-A1442026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889981217204MeridianSeaspine Orthopedics CorporationKWQ2022-08-25
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10889981230869RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230876RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230883RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230890RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231040RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231057RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
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10889981231071RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231088RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
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10889981214494MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214500MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214517MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214524MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
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