FDA.reportPublic FDA data

APTUS

Primary DI
07630037872788
Brand
APTUS
Company
Medartis AG
Model
A-2001.05
Catalog number
A-2001.05
Device description
Screw for Guide Spiral Cutter Prox. Hum.
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181425000APTUS® Proximal Humerus SystemMedartis AG2018-08-05HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037872788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037872788076300378727887630037872788

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
DM exempt
true
Lot or batch
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
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HRS2026-06-01