DEVICE: Ossera™ AFX (00840097517841)

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Device Record History
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Device Identifier (DI) Information
Ossera™ AFX
1743-3636-N
In Commercial Distribution

Restor3d, Inc.
00840097517841
GS1

1
080819836 *Terms of Use
Ossera™ AFX, Half Pill, 36x36
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Device Characteristics
MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61617 Metallic osteotomy fusion cage, non-customized
A 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)].
Active true
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FDA Product Code

[?]
Product Code Product Code Name
SAI Ankle Fusion Cage
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K242356 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
e2167cc3-d44f-4a92-9f8d-a895f45f9a3f
May 29, 2025
1
May 21, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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