Synicem Shoulder Spacer 48H

GUDID 15060155712229

48mm Head, 120 mm Stem Length Shoulder spacer with gentamicin is a temporary implant whose main function is to maintain joint space in the interval between 2 stage revision arthroplasties. Aids in treatment of infection originating in the implant of shoulder prosthesis. Shoulder spacer has a surgical steel center coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.

BIOCOMPOSITES LTD

Orthopaedic cement spacer

• Primary Device ID: 15060155712229
• NIH Device Record Key: cbf9b4af-b1df-471b-8887-1e39b50355fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synicem Shoulder Spacer 48H
• Version Model Number: 885447
• Company DUNS: 424382307
• Company Name: BIOCOMPOSITES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060155712229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242865

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2025-07-16
• Device Publish Date: 2025-07-08

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