FDA.reportPublic FDA data

APTUS

Primary DI
07630894825941
Brand
APTUS
Company
Medartis AG
Model
A-8211.65/1S
Catalog number
A-8211.65/1S
Device description
5.0 CCS Long Thread 65/26mm, 1/Pkg
Published
2025-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K202589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202589000APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AG2020-11-06HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894825941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894825941076308948259417630894825941

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

Regulatory Flags#

DUNS number
480054895
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894827723AVENGERM07S0011M07S00112026-10-13
07630894827730AVENGERM07S002AM07S002A2026-10-13
07630894827747AVENGERM07S002BM07S002B2026-10-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784530CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19