FDA.reportPublic FDA data

APTUS

Primary DI
07630037866619
Brand
APTUS
Company
Medartis AG
Model
A-4899.01
Catalog number
A-4899.01
Device description
Insert for Suture Fixation Clavicle
Published
2023-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTNWASHER, BOLT NUT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192984000APTUS Clavicle SystemMedartis AG2020-01-24HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037831488PreviousGS10
07630037866619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037831488076300378314887630037831488
07630037866619076300378666197630037866619

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
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
07630894821424APTUSP-4031.01P-4031.012026-10-27
07630894821431APTUSP-4031.02P-4031.022026-10-27
07630894821448APTUSP-4031.03P-4031.032026-10-27
07630894821455APTUSP-4031.04P-4031.042026-10-27
07630894821462APTUSP-4031.05P-4031.052026-10-27
07630894821479APTUSP-4031.06P-4031.062026-10-27
07630894821486APTUSP-4031.07P-4031.072026-10-27
07630894821493APTUSP-4031.08P-4031.082026-10-27
07630894821509APTUSP-4031.09P-4031.092026-10-27
07630894821516APTUSP-4031.10P-4031.102026-10-27
07630894821523APTUSP-4031.21P-4031.212026-10-27
07630894821530APTUSP-4031.22P-4031.222026-10-27
07630894821547APTUSP-4031.23P-4031.232026-10-27
07630894821554APTUSP-4031.24P-4031.242026-10-27
07630894821561APTUSP-4031.30/1P-4031.30/12026-10-27
07630894821578APTUSP-4031.01SP-4031.01S2026-10-27
07630894821585APTUSP-4031.02SP-4031.02S2026-10-27
07630894821592APTUSP-4031.03SP-4031.03S2026-10-27
07630894821608APTUSP-4031.04SP-4031.04S2026-10-27
07630894821615APTUSP-4031.05SP-4031.05S2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
B56251201WR0070T00WishBone Plate & Screw SystemWishbone Medical, Inc.HTN2022-07-18
B56251201WR0070T10WishBone Plate & Screw SystemWishbone Medical, Inc.HTN2022-07-18
00863176000317FIBULINKSynthes GmbHHTN2020-03-26
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00889024483668NCB®Zimmer GmbHHTN2017-07-28
00863176000300FIBULINKSynthes GmbHHTN2017-06-08
00888867196537Arthrex®ARTHREX, INC.HTN2017-05-11
00888867196582Arthrex®ARTHREX, INC.HTN2017-05-11
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
00888867026599Arthrex®ARTHREX, INC.HTN2017-02-15
10845854015506CONMEDConmed CorporationHTN2015-12-10
10845854015865CONMEDConmed CorporationHTN2015-12-10
10845854015957CONMEDConmed CorporationHTN2015-12-10