SURESPACE

GUDID 00822409043224

TIBIAL SPACER MOLD MEDIUM

Ortho Development Corporation

Orthopaedic cement spacer mould

• Primary Device ID: 00822409043224
• NIH Device Record Key: b515c676-8655-4f9d-8611-152d6053b6e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURESPACE
• Version Model Number: SST2070
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409043224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133449

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: 2019-10-14
• Device Publish Date: 2019-10-04

On-Brand Devices [SURESPACE]

• 00822409043231: TIBIAL SPACER MOLD LARGE
• 00822409043224: TIBIAL SPACER MOLD MEDIUM
• 00822409043217: TIBIAL SPACER MOLD SMALL
• 00822409043200: FEMORAL SPACER MOLD LARGE
• 00822409043194: FEMORAL SPACER MOLD MEDIUM
• 00822409043187: FEMORAL SPACER MOLD SMALL