Kinos Total Ankle Replacements

GUDID 00840097510774

Range Bearing Implant, Size 3, Left, 8mm

Restor3d, Inc.

Ankle prosthesis bearing
Primary Device ID00840097510774
NIH Device Record Key18f15788-ba69-4cca-b6ab-a2f0aacc3193
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinos Total Ankle Replacements
Version Model Number3832-1308
Company DUNS080819836
Company NameRestor3d, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097510774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-03
Device Publish Date2024-06-25

Devices Manufactured by Restor3d, Inc.

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00840097513782 - Ossera™ AFX2025-05-29 Cannulated Convex Reamer, Ø28
00840097517766 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x34
00840097517773 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x36
00840097517780 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x38
00840097517797 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x40
00840097517803 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x42

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