FDA.reportPublic FDA data

APTUS

Primary DI
07630894822735
Brand
APTUS
Company
Medartis AG
Model
P-6013.12
Catalog number
P-6013.12
Device description
Instr. Tray Prox. Hum., Standard, Bottom
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
FSMTray, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

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
07630894822735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894822735076308948227357630894822735

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
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110133AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112182Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112199Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112205Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112250Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114025Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114636Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114643Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115305Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115770Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116661Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116678Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116685Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078117200KinematX TotalEXTREMITY MEDICAL, LLCFSM2026-11-02