DEVICE: Monkey Rings™ External Fixation System (00889795115614)
Device Identifier (DI) Information
Monkey Rings™ External Fixation System
P45-120-0160
In Commercial Distribution
P45-120-0160
PARAGON 28, INC.
P45-120-0160
In Commercial Distribution
P45-120-0160
PARAGON 28, INC.
5/8 Ring - 160mm
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? |
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48011 | External orthopaedic fixation system, single-use |
An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3bef8e52-bc71-4100-a301-ee4bbc27b0e6
October 24, 2022
1
October 14, 2022
October 24, 2022
1
October 14, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined