APTUS

Primary DI
07630894831096
Brand
APTUS
Company
Medartis AG
Model
A-5788.48/1S
Catalog number
A-5788.48/1S
Device description
2.2 TITAN Nail 48mm
Published
2026-06-01
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
K260934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260934000TITAN Nail; APTUS K-Wire SystemMedartis AG2026-04-17HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894831096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894831096076308948310967630894831096

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.

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630008400613APTUSA-2047A-20472026-07-16
07630008405793APTUSA-6095.05A-6095.052026-07-16
07630008405809APTUSA-6095.06A-6095.062026-07-16
07630008405878APTUSA-6095.13A-6095.132026-07-16
07630008405892APTUSA-6095.15A-6095.152026-07-16
07630008406226APTUSA-6095.61A-6095.612026-07-16
07630008406233APTUSA-6095.62A-6095.622026-07-16
07630008406240APTUSA-6095.63A-6095.632026-07-16
07630008406257APTUSA-6095.64A-6095.642026-07-16
07630008406264APTUSA-6095.65A-6095.652026-07-16
07630008406271APTUSA-6095.66A-6095.662026-07-16
07630008406288APTUSA-6095.67A-6095.672026-07-16
07630008406295APTUSA-6095.70A-6095.702026-07-16
07630008406301APTUSA-6095.71A-6095.712026-07-16
07630008406318APTUSA-6095.72A-6095.722026-07-16
07630008406325APTUSA-6095.73A-6095.732026-07-16
07630008406332APTUSA-6095.74A-6095.742026-07-16
07630008428327APTUSA-6095.68A-6095.682026-07-16
07630008428334APTUSA-6095.69A-6095.692026-07-16
07630008439866APTUSA-3837A-38372026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982096274ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167967ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168018ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168063ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168117ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175740ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175795ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14