ROSA Hip Software 20-8060-400-01

GUDID 00887868525681

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00887868525681
• NIH Device Record Key: a32c0e4d-30c7-4b07-bb63-043edde6fad3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROSA Hip Software
• Version Model Number: 20-8060-400-01
• Catalog Number: 20-8060-400-01
• Company DUNS: 205670032
• Company Name: Orthosoft Inc
• 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: true
• 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	00887868525681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210998

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: 2021-09-01
• Device Publish Date: 2021-08-24

Devices Manufactured by Orthosoft Inc

• 00889024674776 - ROSA POLYAXIAL REFERENCE SIZE 3: 2025-12-19
• 00889024674783 - ROSA POLYAXIAL REFERENCE SIZE 6: 2025-12-19
• 00889024674806 - ROSA STABILIZER TISSUE DEFLECTOR 60MM: 2025-12-19
• 00887868578915 - HAMMR™: 2024-05-01
• 00887868557873 - ROSA® Shoulder: 2024-03-14
• 00887868557880 - ROSA® Shoulder: 2024-03-14
• 00887868557897 - ROSA® Shoulder: 2024-03-14
• 00887868557903 - ROSA® Shoulder: 2024-03-14