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

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
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169371TAURUS LX Pedicle Screw SystemCTL Medical CorporationKWQ2026-11-04
08800322699775AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699782AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800322699799AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704032AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704049AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08800424704056AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719654AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719661AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719678AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719685AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885719692AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799939AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799946AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809885799953AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974809969AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
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08809974819890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
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08809974819944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
B06221006200White Pearl Preferred Angle ACPOsseus Fusion Systems, LLCKWQ2017-10-09