EBI TROCHANTERIC NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

EBI, L.P.

The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Trochanteric Nail System.

Pre-market Notification Details

• Device ID: K050118
• 510k Number: K050118
• Device Name: EBI TROCHANTERIC NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054
• Contact: Frederic Testa
• Correspondent: Frederic Testa; EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-18
• Decision Date: 2005-02-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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