FDA.reportPublic FDA data

APTUS

Primary DI
07630894811661
Brand
APTUS
Company
Medartis AG
Model
A-4350.81TP
Catalog number
A-4350.81TP
Device description
Template for A-4350.81
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K234062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234062000APTUS Hand Scaphoid PlatesMedartis AG2024-03-21HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894811661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894811661076308948116617630894811661

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630037894865APTUSA-4750.95A-4750.952023-02-24
07630008470937APTUSA-4750.95A-4750.952015-10-24
07630894829079APTUSA-2065A-20652026-01-09
07630037863946APTUSA-5040.42/1SA-5040.42/1S2024-11-03
07630894829062APTUSA-2056A-20562025-12-15
07630037862673APTUSA-4200.43SA-4200.43S2024-11-03
07630037862635APTUSA-4200.41SA-4200.41S2024-11-03
07630037862659APTUSA-4200.42SA-4200.42S2024-11-03
07630037890430APTUSA-4750.192SA-4750.192S2023-03-03
07630037891314APTUSA-4854.01SA-4854.01S2023-03-03
07630037891345APTUSA-4854.04SA-4854.04S2023-03-03
07630037891352APTUSA-4854.05SA-4854.05S2023-03-03
07630037891369APTUSA-4854.06SA-4854.06S2023-03-03
07630037892199APTUSA-4954.03SA-4954.03S2023-03-03
07630037892236APTUSA-4954.07SA-4954.07S2023-03-03
07630037892311APTUSA-4954.13SA-4954.13S2023-03-03
07630037892328APTUSA-4954.14SA-4954.14S2023-03-03
07630037892335APTUSA-4954.15SA-4954.15S2023-03-03
07630037892366APTUSA-4954.18SA-4954.18S2023-03-03
07630037892380APTUSA-4954.20SA-4954.20S2023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986490001CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490018CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490025CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490032CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490049CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490056CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490063CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490087CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490094CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490100CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490117CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490124CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490131CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490148CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490155CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490162CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490179CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490186CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490193CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490209CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490216CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490223CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490230CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490247CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490254CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490261CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490278CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490285CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490292CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490308CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27