DEVICE: OsteoSinter® EVANS wedge 22W x 22L x 10H mm (08437019951535)

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Device Record History
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Device Identifier (DI) Information
OsteoSinter® EVANS wedge 22W x 22L x 10H mm
P00207B1
In Commercial Distribution

AMES MEDICAL PROSTHETIC SOLUTIONS S.A.
08437019951535
GS1

1
468566411 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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
PLF Bone Wedge
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K240461 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
4940be9e-dfe6-41a8-b496-acf5fef64ecb
March 24, 2025
1
March 14, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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