FDA.reportPublic FDA data

Mediant Anterior Cervical Plate

Primary DI
00814033021020
Brand
Mediant Anterior Cervical Plate
Company
INTELLIGENT IMPLANT SYSTEMS, LLC
Model
12102043
Device description
Mediant 43 mm plate, 2-level
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K173935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173935000Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC2018-04-16KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814033021020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814033021020008140330210208140330210200814033021020

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013742030
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814033021266MEDIANT1213021213022019-05-29
00814033021273MEDIANT1213091213092019-05-29
00814033021280MEDIANT1213081213082019-05-29
00814033020900Mediant Anterior Cervical Plate121010192018-05-17
00814033020917Mediant Anterior Cervical Plate121010202018-05-17
00814033020924Mediant Anterior Cervical Plate121010222018-05-17
00814033020931Mediant Anterior Cervical Plate121010242018-05-17
00814033020948Mediant Anterior Cervical Plate121010262018-05-17
00814033020955Mediant Anterior Cervical Plate121010282018-05-17
00814033020962Mediant Anterior Cervical Plate121010302018-05-17
00814033020979Mediant Anterior Cervical Plate121010322018-05-17
00814033020986Mediant Anterior Cervical Plate121010342018-05-17
00814033020993Mediant Anterior Cervical Plate121010362018-05-17
00814033021006Mediant Anterior Cervical Plate121020372018-05-17
00814033021013Mediant Anterior Cervical Plate121020402018-05-17
00814033021037Mediant Anterior Cervical Plate121020462018-05-17
00814033021044Mediant Anterior Cervical Plate121020492018-05-17
00814033021051Mediant Anterior Cervical Plate121020522018-05-17
00814033021068Mediant Anterior Cervical Plate121020552018-05-17
00814033021075Mediant Anterior Cervical Plate121030542018-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986492791CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
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