FDA.reportPublic FDA data

APTUS

Primary DI
07630037866442
Brand
APTUS
Company
Medartis AG
Model
A-4099.02/1S
Catalog number
A-4099.02/1S
Device description
3.5 Wedge Screw 11mm, HD15
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
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLFBone WedgeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037866442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037866442076300378664427630037866442

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

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
G817103151100SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817103151200SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
00810199190006ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190013ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190020ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24