Kinos Instrumentation

Primary DI
00840097511689
Brand
Kinos Instrumentation
Company
Restor3d, Inc.
Model
5801-2122
Device description
Anatomic Flat-Cut Surface Trial, Right, Size 2
Published
2024-06-25
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
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192778000Kinos Axiom Total Ankle SystemKinos Medical2020-06-30HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097511689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097511689008400975116898400975116890840097511689

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); 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
080819836
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097513768Ossera™ AFX1741-4600-N2025-05-20
00840097517193Ossera™ AFX1741-3400-N2025-05-20
00840097517209Ossera™ AFX1741-3600-N2025-05-20
00840097517216Ossera™ AFX1741-3800-N2025-05-20
00840097517223Ossera™ AFX1741-4000-N2025-05-20
00840097517230Ossera™ AFX1741-4200-N2025-05-20
00840097517247Ossera™ AFX1741-4400-N2025-05-20
00840097517254Ossera™ AFX1742-3434-N2025-05-20
00840097517261Ossera™ AFX1742-3436-N2025-05-20
00840097517278Ossera™ AFX1742-3438-N2025-05-20
00840097517285Ossera™ AFX1742-3440-N2025-05-20
00840097517292Ossera™ AFX1742-3442-N2025-05-20
00840097517308Ossera™ AFX1742-3444-N2025-05-20
00840097517315Ossera™ AFX1742-3446-N2025-05-20
00840097517322Ossera™ AFX1742-3634-N2025-05-20
00840097517339Ossera™ AFX1742-3636-N2025-05-20
00840097517346Ossera™ AFX1742-3638-N2025-05-20
00840097517353Ossera™ AFX1742-3640-N2025-05-20
00840097517360Ossera™ AFX1742-3642-N2025-05-20
00840097517377Ossera™ AFX1742-3644-N2025-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534237Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534244Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534251Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534268Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534275Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534282Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00889797111089PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111096PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111102PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111119PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111126PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114820PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114837PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
B095401122Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402112Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402113Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402114Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402121Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402122Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402123Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402124Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095402125Hintermann Series H2Dt Medtech, LLCHSN2018-03-21
B095322305Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322306Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322307Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322315Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322316Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322317Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322325Hintermann Series H2Dt Medtech, LLCHSN2018-03-20
B095322326Hintermann Series H2Dt Medtech, LLCHSN2018-03-20