DEVICE: Neo Medical Cage kit (07640177822611)

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Device Record History
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Device Identifier (DI) Information
Neo Medical Cage kit
AC-36-07-05
In Commercial Distribution
AC-36-07-05
Neo Medical SA
07640177822611
GS1

1
486778843 *Terms of Use
Cage anatomical curved 36mm, 7 mm, 5 °
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Device Characteristics
MR Conditional
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?
38161 Metallic spinal interbody fusion cage
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K191796 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 7 Millimeter
Length: 36 Millimeter
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Device Record Status
8b835b83-7873-4537-a1f1-278fb45705d9
July 14, 2025
4
January 06, 2020
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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