SpaceFlex Hip Instrument Kit

GUDID 08058964726186

SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.

G21 SRL

Orthopaedic cement spacer mould

• Primary Device ID: 08058964726186
• NIH Device Record Key: a7276257-b923-41b0-921b-e2a544441611
• Commercial Distribution Discontinuation: 2019-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SpaceFlex Hip Instrument Kit
• Version Model Number: 900008
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	08058964726186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192041

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08058964726186]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

Devices Manufactured by G21 SRL

• 08058964729217 - CeMend Shoulder Spacer: 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain
• 08058964729224 - CeMend Shoulder Spacer: 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain
• 08058964729231 - CeMend Shoulder Spacer: 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain
• 08058964729248 - CeMend Shoulder Spacer: 2025-12-29 The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stain
• 08058964729255 - CeMend Shoulder Spacer Reamer Tray: 2025-12-29 Tray
• 08058964729262 - Reamer T-handle: 2025-12-29 T-handle for reamer
• 08058964729279 - CeMend Reamer 8mm: 2025-12-29 Reamer with diameter 8mm
• 08058964729286 - CeMend Reamer 10mm: 2025-12-29 Reamer with diameter 10mm