PeekMed web

GUDID 05600120304818

PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In the case of a 3D 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, e.g. screws, fixation plates, or full prosthesis, deriving from several producing companies. The software imports diagnostic imaging studies (e.g. X-rays or Computed Tomography (CT)) from a storage (e.g., CD Rom, local folder). In parallel, there is a database containing digital representations of prosthetic materials (templates) supplied by their respective manufacturers, which offers the possibility of inserting templates during the surgery planning. As PeekMed web is capable of representing the medical images in a 2D and/or 3D environment, performing relevant measurements on those images and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.

PEEK HEALTH, S.A.

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 05600120304818
• NIH Device Record Key: c6c6f742-60da-4d0c-ae3d-4b6f7f6d5ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeekMed web
• Version Model Number: v1
• Company DUNS: 338110102
• Company Name: PEEK HEALTH, S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05600120304818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240926

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by PEEK HEALTH, S.A.

• 05600120304801 - PeekMed: 2025-03-28 PeekMed is a system that allows healthcare professionals to plan a surgery procedure simulating various environments, from hybri
• 05600120304818 - PeekMed web: 2025-03-28PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In the case of a 3D 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, e.g. screws, fixation plates, or full prosthesis, deriving from several producing companies. The software imports diagnostic imaging studies (e.g. X-rays or Computed Tomography (CT)) from a storage (e.g., CD Rom, local folder). In parallel, there is a database containing digital representations of prosthetic materials (templates) supplied by their respective manufacturers, which offers the possibility of inserting templates during the surgery planning. As PeekMed web is capable of representing the medical images in a 2D and/or 3D environment, performing relevant measurements on those images and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
• 05600120304818 - PeekMed web: 2025-03-28 PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In t