DEVICE: Intelliguides (G2710400460260)
Device Identifier (DI) Information
Intelliguides
Tibial TruArc
In Commercial Distribution
04-0046-026
Mios Marketing, LLC
Tibial TruArc
In Commercial Distribution
04-0046-026
Mios Marketing, LLC
Anterior Dome Osteotomy Guide, 46mm x 26mm
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? |
---|---|---|---|---|
63198 | Orthopaedic implant aiming/guiding block, single-use |
A sterile surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PBF | Orthopaedic Surgical Planning And Instrument Guides |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K220717 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 46 Millimeter |
Depth: 26 Millimeter |
Device Record Status
4fad972d-1882-4dff-b094-b5f299c99d21
January 09, 2023
1
January 01, 2023
January 09, 2023
1
January 01, 2023
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
877-334-3668
customerservice@redpointmedical3d.com
customerservice@redpointmedical3d.com