FDA.reportPublic FDA data

APTUS

Primary DI
07630037863144
Brand
APTUS
Company
Medartis AG
Model
A-4300.70/1
Catalog number
A-4300.70/1
Device description
1.2/1.5 Biconcave Washer, 1/Pkg
Published
2023-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051567000APTUS TITANIUM OSTEOSYNTHESIS SYSTEMMedartis, Inc.2005-08-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630008432874PreviousGS10
07630037863144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630008432874076300084328747630008432874
07630037863144076300378631447630037863144

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894821424APTUSP-4031.01P-4031.012026-10-27
07630894821431APTUSP-4031.02P-4031.022026-10-27
07630894821448APTUSP-4031.03P-4031.032026-10-27
07630894821455APTUSP-4031.04P-4031.042026-10-27
07630894821462APTUSP-4031.05P-4031.052026-10-27
07630894821479APTUSP-4031.06P-4031.062026-10-27
07630894821486APTUSP-4031.07P-4031.072026-10-27
07630894821493APTUSP-4031.08P-4031.082026-10-27
07630894821509APTUSP-4031.09P-4031.092026-10-27
07630894821516APTUSP-4031.10P-4031.102026-10-27
07630894821523APTUSP-4031.21P-4031.212026-10-27
07630894821530APTUSP-4031.22P-4031.222026-10-27
07630894821547APTUSP-4031.23P-4031.232026-10-27
07630894821554APTUSP-4031.24P-4031.242026-10-27
07630894821561APTUSP-4031.30/1P-4031.30/12026-10-27
07630894821578APTUSP-4031.01SP-4031.01S2026-10-27
07630894821585APTUSP-4031.02SP-4031.02S2026-10-27
07630894821592APTUSP-4031.03SP-4031.03S2026-10-27
07630894821608APTUSP-4031.04SP-4031.04S2026-10-27
07630894821615APTUSP-4031.05SP-4031.05S2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986485137CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485144CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485151CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485168CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485274CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485281CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485298CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485304CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485311CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485328CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485335CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485342CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485359CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485366CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485373CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485380CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485397CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485403CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485410CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485427CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485434CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485441CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485458CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485465CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485472CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485588CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485595CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485601CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485618CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485625CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29