FDA.reportPublic FDA data

APTUS

Primary DI
07630037884460
Brand
APTUS
Company
Medartis AG
Model
A-5850.30/1S
Catalog number
A-5850.30/1S
Device description
2.8 TriLock Screw 30mm, HD7
Published
2024-11-01
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037884460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037884460076300378844607630037884460

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

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
07630037894865APTUSA-4750.95A-4750.952023-02-24
07630008470937APTUSA-4750.95A-4750.952015-10-24
07630894829079APTUSA-2065A-20652026-01-09
07630037863946APTUSA-5040.42/1SA-5040.42/1S2024-11-03
07630894829062APTUSA-2056A-20562025-12-15
07630037862673APTUSA-4200.43SA-4200.43S2024-11-03
07630037862635APTUSA-4200.41SA-4200.41S2024-11-03
07630037862659APTUSA-4200.42SA-4200.42S2024-11-03
07630037890430APTUSA-4750.192SA-4750.192S2023-03-03
07630037891314APTUSA-4854.01SA-4854.01S2023-03-03
07630037891345APTUSA-4854.04SA-4854.04S2023-03-03
07630037891352APTUSA-4854.05SA-4854.05S2023-03-03
07630037891369APTUSA-4854.06SA-4854.06S2023-03-03
07630037892199APTUSA-4954.03SA-4954.03S2023-03-03
07630037892236APTUSA-4954.07SA-4954.07S2023-03-03
07630037892311APTUSA-4954.13SA-4954.13S2023-03-03
07630037892328APTUSA-4954.14SA-4954.14S2023-03-03
07630037892335APTUSA-4954.15SA-4954.15S2023-03-03
07630037892366APTUSA-4954.18SA-4954.18S2023-03-03
07630037892380APTUSA-4954.20SA-4954.20S2023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10