4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.

Plate, Fixation, Bone

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for 4.5mm Locking Broad & Narrow Compression Plates, 4.5mm & 5.5mm Cortical & Cancellous Locking Screws, Respectively..

Pre-market Notification Details

• Device ID: K072423
• 510k Number: K072423
• Device Name: 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
• Classification: Plate, Fixation, Bone
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Suzana Otano
• Correspondent: Suzana Otano; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-29
• Decision Date: 2007-11-07
• Summary: summary

NIH GUDID Devices

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