PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY

Plate, Fixation, Bone

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Periarticular Locked Plating System For The Upper Extremity.

Pre-market Notification Details

• Device ID: K061352
• 510k Number: K061352
• Device Name: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
• Classification: Plate, Fixation, Bone
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: David Henley
• Correspondent: David Henley; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: KTT
• Subsequent Product Code: LXT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-15
• Decision Date: 2006-06-08
• Summary: summary

NIH GUDID Devices

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