Naviplan

GUDID 07640176970535

NAVIPLAN, CT Planning Software for Total Hip Replacement

Naviswiss AG

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 07640176970535
• NIH Device Record Key: c689026b-acef-49c7-bb4a-7ad971475dd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Naviplan
• Version Model Number: NS053
• Company DUNS: 483929829
• Company Name: Naviswiss AG
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640176970535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211429

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: 2021-10-26
• Device Publish Date: 2021-10-18

Devices Manufactured by Naviswiss AG

• 07640176971327 - Sizer Adapter: 2025-11-26 Instrument for surgical navigation.
• 07640176970740 - Resection Checker: 2025-08-20 Surgical instrument to validate cuts
• 07640176970016 - Navigation unit: 2024-05-24 Navigation unit
• 07640176970023 - Control unit: 2024-05-24 Control unit
• 07640176970108 - Set of NAVItags (sterile, single-use): 2024-05-24 Set of NAVItags (sterile, single-use)
• 07640176970115 - Tag adapter P: 2024-05-24 Tag adapter P
• 07640176970122 - Tag adapter M (magnetic): 2024-05-24 Tag adapter M (magnetic)
• 07640176970153 - Hex screwdriver SW3.5mm (AO coupling): 2024-05-24 Hex screwdriver SW3.5mm (AO coupling)