FDA.reportPublic FDA data

Ossera™ AFX

Primary DI
00840097517667
Brand
Ossera™ AFX
Company
Restor3d, Inc.
Model
1742-4446-N
Device description
Ossera™ AFX, Pill, 44x46
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
HSBRod, Fixation, Intramedullary And Accessories
SAIAnkle Fusion Cage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
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
00840097517667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097517667008400975176678400975176670840097517667

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
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
18059015376838Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376845Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376852Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376869Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376876Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376883Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376890Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376906Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376913Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376920Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376937Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376944Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376951Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376968Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376975Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376982Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376999Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377002Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377019Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377026Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377033Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377040Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377057Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377064Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377071Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377088Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377095Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377101Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015377118Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
00840097513768Ossera™ AFXRestor3d, Inc.HSB2025-05-20