FDA.reportPublic FDA data

Ossera™ AFX Instrumentation

Primary DI
00840097534558
Brand
Ossera™ AFX Instrumentation
Company
Restor3d, Inc.
Model
5742-3634
Device description
Ossera AFX™ Trial, Pill 36D x 34H
Published
2025-12-18
Public version status
New
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
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
00840097534558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097534558008400975345588400975345580840097534558

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. 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
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
00840097519395Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097519401Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097519418Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097519425Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534800Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534817Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534824Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534831Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534848Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534855Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534862Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534879Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534886Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534893Ossera AFXRestor3d, Inc.SAI2026-08-14
00840097534909Ossera AFXRestor3d, Inc.SAI2026-08-14
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
00840097513270Ossera™ 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