Spectrum GV

GUDID 00855195006616

Spectrum GV Bone Cement -1x40

OSTEOREMEDIES, LLC

Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer Orthopaedic cement spacer

• Primary Device ID: 00855195006616
• NIH Device Record Key: 1f4af750-4cb9-41c3-83fb-cf5dc3b9c6f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectrum GV
• Version Model Number: SPECTRUM40
• 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	00855195006616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172906

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-11-20

Devices Manufactured by OSTEOREMEDIES, LLC

• 00850011453285 - BioBrush: 2024-01-05 BioBrush Powered Debridement Device (Large Brush)
• 00850011453278 - Remedy Spacer: 2023-09-18 REMEDY® Stemmed Knee - Adjunct Base
• 00850011453230 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Component 150, 13/11 OD
• 00850011453247 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Component 230, 13/11 OD
• 00850011453254 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Trial 150, 13/11 OD
• 00850011453261 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Trial 230, 13/11 OD
• 00850011453001 - Remedy Spacer: 2022-12-13 REMEDY® RADEL® Humeral Head Trial 40mm
• 00850011453018 - Remedy Spacer: 2022-12-13 REMEDY® RADEL® Humeral Head Trial 45mm