OsteoBridge™ IKA Knee Arthrodesis 10° Spacer GA04041

GUDID 04048266078735

TiAl6V4 ELI sterile

Merete GmbH

Knee arthrodesis prosthesis

• Primary Device ID: 04048266078735
• NIH Device Record Key: a85c2880-7f13-43e9-a21f-1f143404abf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoBridge™ IKA Knee Arthrodesis 10° Spacer
• Version Model Number: 40 50
• Catalog Number: GA04041
• Company DUNS: 313267265
• Company Name: Merete GmbH
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(630)613-7182
• Email: service@merete.medical.com

Device Dimensions

• Length: 50 Millimeter
• Outer Diameter: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266078735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101939

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-01-13
• Device Publish Date: 2015-10-15

Devices Manufactured by Merete GmbH

• 04048266164346 - Merete® CS Cortical Screw Fully Threaded: 2024-03-27 TiAl6V4ELI non-sterile
• 04048266010322 - TwistCut™ EndoSorb bioabsorbable Snap-Off Screw: 2023-09-18 PLGA sterile
• 04048266040664 - OsteoBridge™ Clamping Screw: 2023-07-25 QTY 1
• 04048266141019 - MetaFix™ LS Locking Screw: 2023-07-25 TiAl6V4 ELI sterile
• 04048266141026 - MetaFix™ LS Locking Screw: 2023-07-25 TiAl6V4 ELI sterile
• 04048266141033 - MetaFix™ LS Locking Screw: 2023-07-25 TiAl6V4 ELI sterile
• 04048266141040 - MetaFix™ LS Locking Screw: 2023-07-25 TiAl6V4 ELI sterile
• 04048266141064 - MetaFix™ LS Locking Screw: 2023-07-25 TiAl6V4 ELI sterile