Remedy Spectrum GV Spacer

GUDID 00855195006531

REMEDY SPECTRUM GV Femoral Head - 54mm

OSTEOREMEDIES, LLC

Orthopaedic cement spacer

• Primary Device ID: 00855195006531
• NIH Device Record Key: bb6257b8-29e3-4d71-9d6d-545c5540573f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Spectrum GV Spacer
• Version Model Number: GVHDMD
• 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	00855195006531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172906

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

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

On-Brand Devices [Remedy Spectrum GV Spacer]

• 00855195006609: REMEDY SPECTRUM GV Femoral Long Stem LG
• 00855195006593: REMEDY SPECTRUM GV Femoral Long Stem MD
• 00855195006586: REMEDY SPECTRUM GV Femoral Long Stem SM
• 00855195006579: REMEDY SPECTRUM GV Femoral Stem LG
• 00855195006562: REMEDY SPECTRUM GV Femoral Stem MD
• 00855195006555: REMEDY SPECTRUM GV Femoral Stem SM
• 00855195006548: REMEDY SPECTRUM GV Femoral Head - 60mm
• 00855195006531: REMEDY SPECTRUM GV Femoral Head - 54mm
• 00855195006524: REMEDY SPECTRUM GV Femoral Head - 46mm
• 00850011453063: REMEDY SPECTRUM® GV Femoral Head - 40mm