FDA.report

Ossera™ AFX Instrumentation

Primary DI
00840097534398
Brand
Ossera™ AFX Instrumentation
Company
Restor3d, Inc.
Model
5740-9803
Device description
Ossera AFX™ Tray – Top Level
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
SAIAnkle Fusion Cage

Product Code Classifications

CodeDeviceSpecialtyClass
SAIAnkle Fusion CageOrthopedic2

Premarket Submissions

SubmissionSupplement
K242356000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K242356000TIDAL Fusion Cage SystemRestor3D, Inc.2025-03-24SAI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840097534398PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840097534947Total Knee Instrumentation 5201-10012025-10-10
00840097534954Total Knee Instrumentation 5201-10022025-10-10
00840097534961Total Knee Instrumentation 5201-10032025-10-10
00840097513256Ossera™ AFX Instrumentation5740-00012025-12-18
00840097513263Ossera™ AFX Instrumentation5740-00022025-12-18
00840097513270Ossera™ AFX Instrumentation5740-00032025-12-18
00840097513287Ossera™ AFX Instrumentation5740-34262025-12-18
00840097515724Ossera™ AFX Instrumentation5740-34362025-12-18
00840097515731Ossera™ AFX Instrumentation5740-34402025-12-18
00840097519333Ossera™ AFX1740-34262025-12-18
00840097519340Ossera™ AFX1740-34362025-12-18
00840097519357Ossera™ AFX1740-36322025-12-18
00840097519364Ossera™ AFX1740-36422025-12-18
00840097519371Ossera™ AFX1740-40362025-12-18
00840097519388Ossera™ AFX1740-40462025-12-18
00840097532370Ossera™ AFX Instrumentation5740-36322025-12-18
00840097532387Ossera™ AFX Instrumentation5740-36362025-12-18
00840097533599Ossera™ AFX Instrumentation5741-24012025-12-18
00840097533612Ossera™ AFX Instrumentation5741-34012025-12-18
00840097533629Ossera™ AFX Instrumentation5741-36012025-12-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00840097534411Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097534428Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18