SpaceFlex Knee

GUDID 08058964727039

Orthopedic bone cement modular spacer for temporary knee prosthesis

G21 SRL

Orthopaedic cement spacer mould

• Primary Device ID: 08058964727039
• NIH Device Record Key: 95419a84-df21-4af1-9936-5403fc15a4db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpaceFlex Knee
• Version Model Number: 900189 80
• Company DUNS: 431529195
• Company Name: G21 SRL
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964727039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201960

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: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [SpaceFlex Knee]

• 08058964726940: 900189 70
• 08058964726933: 900189 60
• 08058964727039: Orthopedic bone cement modular spacer for temporary knee prosthesis