FDA.reportPublic FDA data

UNIPLATE

Primary DI
10705034180694
Brand
UNIPLATE
Company
DEPUY SPINE, LLC
Model
189706114
Catalog number
189706114
Device description
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM LARGE DIAMETER SCREW 5.2 x 14mm
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
K042544000
K171439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042544000UNIPLATE ANTERIOR CERVICAL PLATE SYSTEMDepuy Spine, Inc.2004-11-23KWQ
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
10705034180694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503418069410705034180694

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
107105876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034245973CONDUIT2761-01-0152761010152015-09-24
10705034245980CONDUIT2761-01-0102761010102015-09-24
10705034245997CONDUIT2761-01-0052761010052015-09-24
10705034245966CONDUIT2761-01-0302761010302015-09-24
10705034604572CROSSNAV3020-20-0012025-02-14
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18

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
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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
08809974809976AnyPlus 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
08809974819937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
08809974819944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KWQ2026-11-03
B06221006200White Pearl Preferred Angle ACPOsseus Fusion Systems, LLCKWQ2017-10-09