FDA.reportPublic FDA data

Ossera™ AFX Instrumentation

Primary DI
00840097534442
Brand
Ossera™ AFX Instrumentation
Company
Restor3d, Inc.
Model
5741-4000
Device description
Ossera AFX™ Trial, Dome, 40D
Published
2025-12-18
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
00840097534442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097534442008400975344428400975344420840097534442

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097503011restor3d Osteotomy Wedge1100-002-221409072021-09-01
00840097503028restor3d Osteotomy Wedge1100-002-221410072021-09-01
00840097503073restor3d Osteotomy Wedge1100-002-221405072021-09-01
00840097503080restor3d Osteotomy Wedge1100-002-221406072021-09-01
00840097503097restor3d Osteotomy Wedge1100-002-221407072021-09-01
00840097503103restor3d Osteotomy Wedge1100-002-221408072021-09-01
00840097504674restor3d Osteotomy Wedge1100-002-221405102022-08-18
00840097504681restor3d Osteotomy Wedge1100-002-221406132022-08-18
00840097504698restor3d Osteotomy Wedge1100-002-221407152022-08-18
00840097504704restor3d Osteotomy Wedge1100-002-221408182022-08-18
00840097504711restor3d Osteotomy Wedge1100-002-221410232022-08-18
00840097504728restor3d Osteotomy Wedge1100-002-221412282022-08-18
00840097504735restor3d Osteotomy Wedge1100-002-181205132022-08-18
00840097504742restor3d Osteotomy Wedge1100-002-181206162022-08-18
00840097504759restor3d Osteotomy Wedge1100-002-181207192022-08-18
00840097504766restor3d Osteotomy Wedge1100-002-181208222022-08-18
00840097504773restor3d Osteotomy Wedge1100-002-181210282022-08-18
00840097504780restor3d Osteotomy Wedge1100-002-181212342022-08-18
00840097503110restor3d Disposable Instrument, Wedge Trial6100-NSP-A04052021-11-15
00840097503127restor3d Disposable Instrument, Wedge Trial6100-NSP-A05062021-11-15

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