DRIVERS

Driver, Surgical, Pin

ORTHOPEDIC EQUIPMENT CO., INC.

The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Drivers.

Pre-market Notification Details

• Device ID: K781450
• 510k Number: K781450
• Device Name: DRIVERS
• Classification: Driver, Surgical, Pin
• Applicant: ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GFC
• CFR Regulation Number: 878.4820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-08-23
• Decision Date: 1978-09-27