FDA.reportPublic FDA data

APTUS

Primary DI
07630894823053
Brand
APTUS
Company
Medartis AG
Model
A-4851.61TP
Catalog number
A-4851.61TP
Device description
Template for A-4851.61
Published
2026-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K260761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260761000APTUS Clavicle System 2.8Medartis AG2026-06-05HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894823053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894823053076308948230537630894823053

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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