FDA.reportPublic FDA data

restor3d Kinos Axiom PSR

Primary DI
00840097509938
Brand
restor3d Kinos Axiom PSR
Company
Restor3d, Inc.
Model
5831-9005
Device description
Kinos Axiom Coupled PSR, Chamfer-cut
Published
2023-09-27
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
OYKAnkle Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYKAnkle Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223326000Axiom PSR SystemRestor3D2023-03-30OYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097509938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097509938008400975099388400975099380840097509938

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, single-useA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097513201Velora Acetabular System InstrumentationED-06105-C022026-08-21
00840097514789Kinos Aeros Instrumentation5871-00152026-08-21
00840097514796Kinos Aeros Instrumentation5871-00742026-08-21
00840097514802Kinos Aeros Instrumentation5871-00762026-08-21
00840097514819Kinos Aeros Instrumentation5871-00782026-08-21
00840097514826Kinos Aeros Instrumentation5871-09022026-08-21
00840097514833Kinos Aeros Instrumentation5871-09202026-08-21
00840097514840Kinos Aeros Instrumentation5871-09212026-08-21
00840097514857Kinos Aeros Instrumentation5871-10312026-08-21
00840097514864Kinos Aeros Instrumentation5871-10322026-08-21
00840097514871Kinos Aeros Instrumentation5871-10332026-08-21
00840097514888Kinos Aeros Instrumentation5871-10342026-08-21
00840097514895Kinos Aeros Instrumentation5871-10352026-08-21
00840097514901Kinos Aeros Instrumentation5871-10462026-08-21
00840097514918Kinos Aeros Instrumentation5871-10472026-08-21
00840097515694Kinos Aeros Instrumentation5871-00722026-08-21
00840097515700Kinos Aeros Instrumentation5871-42012026-08-21
00840097515717Kinos Aeros Instrumentation5871-42022026-08-21
00840097533742Kinos Aeros Instrumentation5871-11542026-08-21
00840097533759Kinos Aeros Instrumentation5871-11592026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731147431OPTIXVILEX LLCOYK2026-03-03
00816847022736Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022767Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022774Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022781Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022798Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022804Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022811Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022828Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022835Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022842Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00840097509914restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509921restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509945restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097508924restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508931restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508948restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508955restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00816847022576Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022606Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022583Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022590Vantage PSI3D SYSTEMS, INC.OYK2020-11-13