Ossera™ AFX

GUDID 00840097532196

Ossera™ AFX, Rectangle, 52x34x74

Restor3d, Inc.

Metallic osteotomy fusion cage, non-customized
Primary Device ID00840097532196
NIH Device Record Key25779936-a440-4af9-8f6a-0aa4412466e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOssera™ AFX
Version Model Number1744-5274-N
Company DUNS080819836
Company NameRestor3d, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097532196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SAIAnkle Fusion Cage

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


[00840097532196]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-29
Device Publish Date2025-05-21

Devices Manufactured by Restor3d, Inc.

00840097513744 - restor3d Anatomic Bone Model2025-05-30 Anatomic Bone Model
00840097522708 - restor3d Guidewire2025-05-30 Guidewire, Single Trocar, 1.6mm x 5"
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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