FDA.reportPublic FDA data

APTUS

Primary DI
07630894821769
Brand
APTUS
Company
Medartis AG
Model
P-5031.20/1
Catalog number
P-5031.20/1
Device description
3.5 Cortical Screw 20mm, HD15, 1/Pkg
Published
2026-10-27
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
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, 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
07630894821769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894821769076308948217697630894821769

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
true
Serial number
false
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
07630894821714APTUSMedartis AGHWC2026-10-27
07630894821721APTUSMedartis AGHWC2026-10-27
07630894821738APTUSMedartis AGHWC2026-10-27
07630894821745APTUSMedartis AGHWC2026-10-27
07630894821752APTUSMedartis AGHWC2026-10-27
07630894821776APTUSMedartis AGHWC2026-10-27
07630894821783APTUSMedartis AGHWC2026-10-27
07630894821790APTUSMedartis AGHWC2026-10-27
07630894821806APTUSMedartis AGHWC2026-10-27
07630894821813APTUSMedartis AGHWC2026-10-27
07630894821820APTUSMedartis AGHWC2026-10-27
07630894821837APTUSMedartis AGHWC2026-10-27
07630894821851APTUSMedartis AGHWC2026-10-27
07630894821875APTUSMedartis AGHWC2026-10-27
07630894821899APTUSMedartis AGHWC2026-10-27
07630894821912APTUSMedartis AGHWC2026-10-27
07630894821936APTUSMedartis AGHWC2026-10-27
07630894821950APTUSMedartis AGHWC2026-10-27
07630894821974APTUSMedartis AGHWC2026-10-27
07630894821998APTUSMedartis AGHWC2026-10-27
07630894822018APTUSMedartis AGHWC2026-10-27
07630894822032APTUSMedartis AGHWC2026-10-27
07630894822056APTUSMedartis AGHWC2026-10-27
07630894822070APTUSMedartis AGHWC2026-10-27
07630894822094APTUSMedartis AGHWC2026-10-27
07630894822117APTUSMedartis AGHWC2026-10-27
07630894822131APTUSMedartis AGHWC2026-10-27
07630894822155APTUSMedartis AGHWC2026-10-27
07630894822179APTUSMedartis AGHWC2026-10-27
07630894822193APTUSMedartis AGHWC2026-10-27