Remedy Spacer

GUDID 00855195006494

Unite AB Bone Cement

OSTEOREMEDIES, LLC

Orthopaedic cement, medicated

• Primary Device ID: 00855195006494
• NIH Device Record Key: 585a4e93-2b5f-4c2d-9534-96c5c4255e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Spacer
• Version Model Number: UNITE40
• Company DUNS: 079596704
• Company Name: OSTEOREMEDIES, LLC
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00855195006494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092773

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-06

On-Brand Devices [Remedy Spacer]

• 00855195006517: Remedy Acetabular Cup
• 00855195006500: Remedy Femoral Component 84mm
• 00855195006494: Unite AB Bone Cement
• 00855195006487: Remedy Modular Humeral Stem Large
• 00855195006470: Remedy Modular Humeral Stem Medium
• 00855195006463: Remedy Modular Humeral Stem Small
• 00855195006456: Remedy Modular Humeral Head 50mm
• 00855195006449: Remedy Modular Humeral Head 45mm
• 00855195006432: Remedy Modular Humeral Head 40mm
• 00855195006425: Remedy Tibial Insert 80mm
• 00855195006418: Remedy Tibial Insert 70mm
• 00855195006401: Remedy Tibial Insert 60mm
• 00855195006395: Remedy Femoral Component 74mm
• 00855195006388: Remedy Femoral Component 64mm
• 00855195006371: Remedy Femoral Component 54mm
• 00855195006364: Remedy Tibial Component 80mm
• 00855195006357: Remedy Tibial Component 70mm
• 00855195006340: Remedy Tibial Component 60mm
• 00855195006333: Remedy Modular Long Stem Large
• 00855195006326: Remedy Modular Long Stem Medium
• 00855195006319: Remedy Modular Long Stem Small
• 00855195006302: Remedy Modular Stem Large
• 00855195006296: Remedy Modular Stem Medium
• 00855195006289: Remedy Modular Stem Small
• 00855195006272: Remedy Modular Head 60mm
• 00855195006265: Remedy Modular Head 54mm
• 00855195006258: Remedy Modular Head 46mm
• 00855195006234: Remedy Shoulder Humeral Stem Large
• 00855195006227: Remedy Shoulder Humeral Stem Medium
• 00855195006210: Remedy Shoulder Humeral Stem Small
• 00855195006203: Remedy Shoulder Humeral Head 50mm
• 00855195006197: Remedy Shoulder Humeral Head 45mm
• 00855195006180: Remedy Shoulder Humeral Head 40mm
• 00855195006173: Remedy Tibial Insert Wedge 80mm
• 00855195006166: Remedy Tibial Insert Wedge 70mm
• 00855195006159: Remedy Tibial Insert Wedge 60mm
• 00855195006142: Remedy Femoral Component 74mm
• 00855195006135: Remedy Femoral Component 64mm
• 00855195006128: Remedy Femoral Component 54mm
• 00855195006111: Remedy Tibial Component 80mm
• 00855195006104: Remedy Tibial Component 70mm
• 00855195006098: Remedy Tibial Component 60mm
• 00855195006081: Remedy Modular Long Stem Large
• 00855195006074: Remedy Modular Long Stem Medium
• 00855195006067: Remedy Modular Long Stem Small
• 00855195006050: Remedy Modular Stem Large
• 00855195006043: Remedy Modular Stem Medium
• 00855195006036: Remedy Modular Stem Small
• 00855195006029: Remedy Modular Head 60mm
• 00855195006012: Remedy Modular Head 54mm