EBI OPTILOCK PERIARTICULAR PLATING SYSTEM

Plate, Fixation, Bone

EBI, L.P.

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

Pre-market Notification Details

• Device ID: K061098
• 510k Number: K061098
• Device Name: EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054
• Contact: Jennifer P Harakal
• Correspondent: Jennifer P Harakal; EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-19
• Decision Date: 2006-05-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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