FDA.reportPublic FDA data

Ossera™ AFX

Primary DI
00840097517247
Brand
Ossera™ AFX
Company
Restor3d, Inc.
Model
1741-4400-N
Device description
Ossera™ AFX, Dome, Ø44
Published
2025-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00840097517247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097517247008400975172478400975172470840097517247

GMDN Terms#

Term, Definition table
TermDefinition
Metallic osteotomy fusion cage, non-customizedA non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].

Sterilization Methods#

Method table
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 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
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
00840097517384Ossera™ AFX1742-3646-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
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