CeMend Shoulder Spacer

GUDID 08058964729248

The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile, single use and is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection.

G21 SRL

Orthopaedic cement spacer

• Primary Device ID: 08058964729248
• NIH Device Record Key: 652226cb-cfd3-4f50-9d02-45c1edeaa0ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeMend Shoulder Spacer
• Version Model Number: AR-902-1248
• 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: 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	08058964729248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252443

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [CeMend Shoulder Spacer]

• 08058964729248: The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentam
• 08058964729231: The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentam
• 08058964729224: The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentam
• 08058964729217: The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentam