Remedy Spectrum GV Spacer GVHDXS

GUDID 00850011453063

REMEDY SPECTRUM® GV Femoral Head - 40mm

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

• Primary Device ID: 00850011453063
• NIH Device Record Key: 1593e27a-edd9-4024-a946-34db6008c4c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Spectrum GV Spacer
• Version Model Number: GVHDXS
• Catalog Number: GVHDXS
• 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	00850011453063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192995

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: 2020-07-08
• Device Publish Date: 2020-06-30

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