FDA.reportPublic FDA data

APTUS

Primary DI
07630894822544
Brand
APTUS
Company
Medartis AG
Model
P-4031.04TP
Catalog number
P-4031.04TP
Device description
Template for P-4031.01-04
Published
2026-11-02
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
K253916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253916000APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026-03-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894822544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894822544076308948225447630894822544

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
07630894821844APTUSP-5031.28/1P-5031.28/12026-11-02
07630894821868APTUSP-5031.30/1P-5031.30/12026-11-02
07630894821882APTUSP-5031.32/1P-5031.32/12026-11-02
07630894821905APTUSP-5031.34/1P-5031.34/12026-11-02
07630894821929APTUSP-5031.36/1P-5031.36/12026-11-02
07630894821943APTUSP-5031.38/1P-5031.38/12026-11-02
07630894821967APTUSP-5031.40/1P-5031.40/12026-11-02
07630894821981APTUSP-5031.45/1P-5031.45/12026-11-02
07630894822001APTUSP-5031.50/1P-5031.50/12026-11-02
07630894822025APTUSP-5031.55/1P-5031.55/12026-11-02
07630894822049APTUSP-5031.60/1P-5031.60/12026-11-02
07630894822063APTUSP-5032.16/1P-5032.16/12026-11-02
07630894822087APTUSP-5032.18/1P-5032.18/12026-11-02
07630894822100APTUSP-5032.20/1P-5032.20/12026-11-02
07630894822124APTUSP-5032.22/1P-5032.22/12026-11-02
07630894822148APTUSP-5032.24/1P-5032.24/12026-11-02
07630894822162APTUSP-5032.26/1P-5032.26/12026-11-02
07630894822186APTUSP-5032.28/1P-5032.28/12026-11-02
07630894822209APTUSP-5032.30/1P-5032.30/12026-11-02
07630894822223APTUSP-5032.32/1P-5032.32/12026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHRS2024-02-23
00810112592252TriLEAPSynthes GmbHHRS2024-02-23
00810112592429TriLEAPSynthes GmbHHRS2024-02-23
00810112592450TriLEAPSynthes GmbHHRS2024-02-23
00810112592467TriLEAPSynthes GmbHHRS2024-02-23
00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
00810112593013TriLEAPSynthes GmbHHRS2024-02-22
00810112593020TriLEAPSynthes GmbHHRS2024-02-22
00810112593037TriLEAPSynthes GmbHHRS2024-02-22
00810112593044TriLEAPSynthes GmbHHRS2024-02-22
00810112593051TriLEAPSynthes GmbHHRS2024-02-22
00810112593068TriLEAPSynthes GmbHHRS2024-02-22
00810112593075TriLEAPSynthes GmbHHRS2024-02-22
00810112593082TriLEAPSynthes GmbHHRS2024-02-22
00810112593099TriLEAPSynthes GmbHHRS2024-02-22
00810112593105TriLEAPSynthes GmbHHRS2024-02-22
00810112593112TriLEAPSynthes GmbHHRS2024-02-22
00810112593129TriLEAPSynthes GmbHHRS2024-02-22
00810112593136TriLEAPSynthes GmbHHRS2024-02-22
00810112593143TriLEAPSynthes GmbHHRS2024-02-22
00810112593150TriLEAPSynthes GmbHHRS2024-02-22
00810112593167TriLEAPSynthes GmbHHRS2024-02-22
00810112593174TriLEAPSynthes GmbHHRS2024-02-22
00810112593181TriLEAPSynthes GmbHHRS2024-02-22