FDA.reportPublic FDA data

APTUS

Primary DI
07630894811333
Brand
APTUS
Company
Medartis AG
Model
A-6603.020
Catalog number
A-6603.020
Device description
Implant Case APTUS CCS 2.2, 3.0
Published
2024-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K232251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232251000APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG2023-11-03HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630894811333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630894811333076308948113337630894811333

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894829819APTUSA-5788.12/1SA-5788.12/1S2026-06-01
07630894829826APTUSA-5788.14/1SA-5788.14/1S2026-06-01
07630894829833APTUSA-5788.16/1SA-5788.16/1S2026-06-01
07630894829840APTUSA-5788.18/1SA-5788.18/1S2026-06-01
07630894829857APTUSA-5788.20/1SA-5788.20/1S2026-06-01
07630894829864APTUSA-5788.22/1SA-5788.22/1S2026-06-01
07630894829871APTUSA-5788.24/1SA-5788.24/1S2026-06-01
07630894829888APTUSA-5788.26/1SA-5788.26/1S2026-06-01
07630894829895APTUSA-5788.28/1SA-5788.28/1S2026-06-01
07630894829901APTUSA-5788.30/1SA-5788.30/1S2026-06-01
07630894829918APTUSA-5788.32/1SA-5788.32/1S2026-06-01
07630894829925APTUSA-5788.34/1SA-5788.34/1S2026-06-01
07630894829932APTUSA-5788.36/1SA-5788.36/1S2026-06-01
07630894829949APTUSA-5788.38/1SA-5788.38/1S2026-06-01
07630894829956APTUSA-5788.40/1SA-5788.40/1S2026-06-01
07630894829963APTUSA-5788.42/1SA-5788.42/1S2026-06-01
07630894829970APTUSA-5788.44/1SA-5788.44/1S2026-06-01
07630894829987APTUSA-5788.46/1SA-5788.46/1S2026-06-01
07630894829994APTUSA-5788.48/1SA-5788.48/1S2026-06-01
07630894830006APTUSA-5788.50/1SA-5788.50/1S2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01