FDA.reportPublic FDA data

Ossera™ AFX Instrumentation

Primary DI
00840097534176
Brand
Ossera™ AFX Instrumentation
Company
Restor3d, Inc.
Model
5740-9812
Device description
Ossera Convex Reamers Tray – Lid
Published
2026-05-14
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
00840097534176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097534176008400975341768400975341760840097534176

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097534237Kinos Aeros Total Ankle Replacement1844-01022026-07-31
00840097534244Kinos Aeros Total Ankle Replacement1844-01042026-07-31
00840097534251Kinos Aeros Total Ankle Replacement1844-01062026-07-31
00840097534268Kinos Aeros Total Ankle Replacement1844-02042026-07-31
00840097534275Kinos Aeros Total Ankle Replacement1844-02062026-07-31
00840097534282Kinos Aeros Total Ankle Replacement1844-02082026-07-31
00840097536552iTotal Identity CR 3DP Porous5200-39322026-07-31
00840097536569iTotal Identity CR 3DP Porous5200-39352026-07-31
00840097536576iTotal Identity CR 3DP Porous5200-39382026-07-31
00840097536583iTotal Identity CR 3DP Porous5200-39412026-07-31
00840097536590iTotal Identity CR 3DP Porous5200-39442026-07-31
00840097513119Veritas Reverse Total Shoulder6500-90012026-07-24
00840097513126Veritas Reverse Total Shoulder6500-90022026-07-24
00840097513133Veritas Reverse Total Shoulder6500-90032026-07-24
00840097516004Veritas Reverse Total Shoulder1500-9001-P012026-07-24
00840097516011Veritas Reverse Total Shoulder1500-9001-P022026-07-24
00840097534206Velora Acetabular System Instrumentation5900-00052026-07-23
00840097534923Veritas Instrumentation6203-10022026-07-23
00840097534930Veritas Instrumentation6500-20602026-07-23
00840097536699Kinos Aeros Instrumentation5801-10002026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534169Ossera™ 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
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