FDA.reportPublic FDA data

SKYLINE

Primary DI
10705034134628
Brand
SKYLINE
Company
Medos International Sàrl
Model
186862016
Catalog number
186862016
Device description
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 16mm
Published
2015-09-24
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
K052552000
K171439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052552000HYBRID ANTERIOR CERVICAL PLATE SYSTEMDepuy Spine, Inc.2005-10-13KWQ
K171439000EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate SystemMedos International SARL2017-07-20KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034134628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503413462810705034134628

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09
10705034647494CROSSNAV CONDUIT3010-21-3143010213142026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13