FDA.reportPublic FDA data

Skye Cervical Plate System

Primary DI
00195860010594
Brand
Skye Cervical Plate System
Company
Evolution Spine LLC
Model
CP-1005
Catalog number
CP-1005
Device description
Plate Caddy
Published
2021-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195860010594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195860010594001958600105941958600105940195860010594

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

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
DM exempt
true
Premarket exempt
true
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
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
00724995296247V. MuellerSteris CorporationFSM2026-08-21
00724995296254V. MuellerSteris CorporationFSM2026-08-21
00724995296261V. MuellerSteris CorporationFSM2026-08-21
00724995296278V. MuellerSteris CorporationFSM2026-08-21
00724995296285V. MuellerSteris CorporationFSM2026-08-21
00724995296292V. MuellerSteris CorporationFSM2026-08-21
00724995296308V. MuellerSteris CorporationFSM2026-08-21
00724995296315V. MuellerSteris CorporationFSM2026-08-21
00724995296322V. MuellerSteris CorporationFSM2026-08-21
00724995296339V. MuellerSteris CorporationFSM2026-08-21
00724995296346V. MuellerSteris CorporationFSM2026-08-21
00724995296353V. MuellerSteris CorporationFSM2026-08-21
00724995296360V. MuellerSteris CorporationFSM2026-08-21
00724995296377V. MuellerSteris CorporationFSM2026-08-21
00724995296384V. MuellerSteris CorporationFSM2026-08-21
00724995296391V. MuellerSteris CorporationFSM2026-08-21
00724995296407V. MuellerSteris CorporationFSM2026-08-21
00724995296414V. MuellerSteris CorporationFSM2026-08-21
00724995296421V. MuellerSteris CorporationFSM2026-08-21
00724995296438V. MuellerSteris CorporationFSM2026-08-21
00724995296445V. MuellerSteris CorporationFSM2026-08-21