FDA.reportPublic FDA data

Ossera™ AFX

Primary DI
00840097513768
Brand
Ossera™ AFX
Company
Restor3d, Inc.
Model
1741-4600-N
Device description
Ossera™ AFX, Dome, Ø46
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
00840097513768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097513768008400975137688400975137680840097513768

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
00840097513201Velora Acetabular System InstrumentationED-06105-C022026-08-21
00840097514789Kinos Aeros Instrumentation5871-00152026-08-21
00840097514796Kinos Aeros Instrumentation5871-00742026-08-21
00840097514802Kinos Aeros Instrumentation5871-00762026-08-21
00840097514819Kinos Aeros Instrumentation5871-00782026-08-21
00840097514826Kinos Aeros Instrumentation5871-09022026-08-21
00840097514833Kinos Aeros Instrumentation5871-09202026-08-21
00840097514840Kinos Aeros Instrumentation5871-09212026-08-21
00840097514857Kinos Aeros Instrumentation5871-10312026-08-21
00840097514864Kinos Aeros Instrumentation5871-10322026-08-21
00840097514871Kinos Aeros Instrumentation5871-10332026-08-21
00840097514888Kinos Aeros Instrumentation5871-10342026-08-21
00840097514895Kinos Aeros Instrumentation5871-10352026-08-21
00840097514901Kinos Aeros Instrumentation5871-10462026-08-21
00840097514918Kinos Aeros Instrumentation5871-10472026-08-21
00840097515694Kinos Aeros Instrumentation5871-00722026-08-21
00840097515700Kinos Aeros Instrumentation5871-42012026-08-21
00840097515717Kinos Aeros Instrumentation5871-42022026-08-21
00840097533742Kinos Aeros Instrumentation5871-11542026-08-21
00840097533759Kinos Aeros Instrumentation5871-11592026-08-21

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Primary DI, Brand, Company table
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