FDA.reportPublic FDA data

Ossera™ AFX Instrumentation

Primary DI
00840097513270
Brand
Ossera™ AFX Instrumentation
Company
Restor3d, Inc.
Model
5740-0003
Device description
Ossera AFX™ Distractor
Published
2025-12-18
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
SAIAnkle Fusion Cage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAIAnkle Fusion CageOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242356000TIDAL Fusion Cage SystemRestor3D, Inc.2025-03-24SAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097513270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097513270008400975132708400975132700840097513270

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
00840097534169Ossera™ AFX InstrumentationRestor3d, Inc.SAI2026-05-14
00840097534176Ossera™ AFX InstrumentationRestor3d, Inc.SAI2026-05-14
00840097513256Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097513263Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097513287Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097515724Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097515731Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097519333Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519340Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519357Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519364Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519371Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519388Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097532370Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097532387Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533599Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533612Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533629Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533636Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533643Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533650Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533667Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533674Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533711Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097533728Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097533735Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097534367Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097534374Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097534381Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097534398Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18