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

• 04048266076830 - N/A: 2024-10-28 Countersink for 1/4'' Coupling (for Ø 6,5 mm screws) cannulated for Ø2,0 mm K-Wire, non-sterile
• 04048266054401 - DuoThread™: 2024-07-09 DuoThread™ Drill bit Ø2.0 mm, Length: 62 mm, canulated, non-sterile
• 04048266076823 - N/A: 2024-07-09 Double drill sleeve cannulated for K-wire 2.0 and Drill 5.0 non-sterile
• 04048266077080 - N/A: 2024-07-09 T-Handle with 1/4'' chuck (for screws Ø 6,5mm) non-sterile
• 04048266078490 - N/A: 2024-07-09 Small handle coupling for Ao - prug-in part with dia. 17x80 mm - silicone length, knob at the back (demountable), non-sterile
• 04048266167316 - N/A: 2024-07-09 Universal Length Gauge für K-wire 230 mm non-sterile
• 04048266183347 - N/A: 2024-07-08 Drill 2.0 140 AO-Connector color-coated white non-sterile, single-use
• 04048266183354 - N/A: 2024-07-08 Drill 2.5 140 AO-Connector color-coated magenta non-sterile, single-use