ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM

Component, Traction, Invasive

ORTHOFIX SRL

The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Additional Accessories For The Orthofix System.

Pre-market Notification Details

• Device ID: K944092
• 510k Number: K944092
• Device Name: ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
• Classification: Component, Traction, Invasive
• Applicant: ORTHOFIX SRL 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852
• Contact: Robert L Sheridan
• Correspondent: Robert L Sheridan; ORTHOFIX SRL 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852
• Product Code: JEC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-22
• Decision Date: 1995-04-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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