KASM

GUDID 00822409007585

Small 39A/P x 58M/L Tibial Spacer Mold

Ortho Development Corporation

Orthopaedic cement spacer mould

• Primary Device ID: 00822409007585
• NIH Device Record Key: c247a1ad-9b88-4b26-87a1-d96135381e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KASM
• Version Model Number: 669-2058
• 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
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409007585 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-08-31

On-Brand Devices [KASM]

• 00822409007608: Large 52A/P x 81M/L Tibial Spacer Mold
• 00822409007592: Medium 45A/P x 70M/L Tibial Spacer Mold
• 00822409007585: Small 39A/P x 58M/L Tibial Spacer Mold
• 00822409007578: Large 53A/P x 75M/L Femoral Spacer Mold
• 00822409007561: Medium 44A/P x 67M/L Femoral Spacer Mold
• 00822409007554: Small 37A/P x 60M/L Femoral Spacer Mold