DEVICE: PeekMed (05600120304801)
Device Identifier (DI) Information
PeekMed
v2
In Commercial Distribution
PEEK HEALTH, S.A.
v2
In Commercial Distribution
PEEK HEALTH, S.A.
PeekMed is a system that allows healthcare professionals to plan a surgery procedure simulating various
environments, from hybrid (2D/3D) to 3D or 2D environments. In the case of a 3D or hybrid environment,
the healthcare professional can resort to a 3D model generated from a previous imaging study on the
patient and 3D digital representations of the implant material to be used during surgery, i.e. screws, fixation
plates, or full prosthesis, deriving from several producing companies.
Being software it does not interact with any part of the body of the user and/or patient.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
46470 | Orthopaedic/craniofacial implantation planning software |
A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K182464 | 000 |
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
04ef5d20-79ca-41d4-a464-599e558c4316
March 28, 2025
1
March 20, 2025
March 28, 2025
1
March 20, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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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
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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