FDA.reportPublic FDA data

APTUS

Primary DI
07630894822148
Brand
APTUS
Company
Medartis AG
Model
P-5032.24/1
Catalog number
P-5032.24/1
Device description
3.5 PentaLock Screw 24mm, HD15, 1/Pkg
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
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
07630894822148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894822148076308948221487630894822148

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
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
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
07630894822247APTUSP-5032.34/1P-5032.34/12026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592252TriLEAPSynthes GmbHHWC2024-02-23
00810112592429TriLEAPSynthes GmbHHWC2024-02-23
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00810112592474TriLEAPSynthes GmbHHWC2024-02-23
00810112592634TriLEAPSynthes GmbHHWC2024-02-23
00810112592832TriLEAPSynthes GmbHHWC2024-02-23
00810112592849TriLEAPSynthes GmbHHWC2024-02-23
00810112592986TriLEAPSynthes GmbHHWC2024-02-22
00810112592993TriLEAPSynthes GmbHHWC2024-02-22
00810112593006TriLEAPSynthes GmbHHWC2024-02-22
00810112593013TriLEAPSynthes GmbHHWC2024-02-22
00810112593020TriLEAPSynthes GmbHHWC2024-02-22
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00810112593044TriLEAPSynthes GmbHHWC2024-02-22
00810112593051TriLEAPSynthes GmbHHWC2024-02-22
00810112593068TriLEAPSynthes GmbHHWC2024-02-22
00810112593075TriLEAPSynthes GmbHHWC2024-02-22
00810112593082TriLEAPSynthes GmbHHWC2024-02-22
00810112593099TriLEAPSynthes GmbHHWC2024-02-22
00810112593105TriLEAPSynthes GmbHHWC2024-02-22
00810112593112TriLEAPSynthes GmbHHWC2024-02-22
00810112593129TriLEAPSynthes GmbHHWC2024-02-22
00810112593136TriLEAPSynthes GmbHHWC2024-02-22
00810112593143TriLEAPSynthes GmbHHWC2024-02-22
00810112593150TriLEAPSynthes GmbHHWC2024-02-22
00810112593167TriLEAPSynthes GmbHHWC2024-02-22
00810112593174TriLEAPSynthes GmbHHWC2024-02-22
00810112593181TriLEAPSynthes GmbHHWC2024-02-22