PeekMed

GUDID 05600120304801

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.

PEEK HEALTH, S.A.

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 05600120304801
• NIH Device Record Key: 04ef5d20-79ca-41d4-a464-599e558c4316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeekMed
• Version Model Number: v2
• 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	05600120304801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182464

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: 2025-03-28PeekMed 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.
• 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: 2025-03-28 PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In t