TORQUE INSTRUMENT, MODEL 8500

Manipulator, Plunger-like Joint

SPINALIGHT, INC.

The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Torque Instrument, Model 8500.

Pre-market Notification Details

• Device ID: K001476
• 510k Number: K001476
• Device Name: TORQUE INSTRUMENT, MODEL 8500
• Classification: Manipulator, Plunger-like Joint
• Applicant: SPINALIGHT, INC. 1620 ALBRITTON DR. SUITE 7 Kennesaw, GA 30152
• Contact: T. A Cox
• Correspondent: T. A Cox; SPINALIGHT, INC. 1620 ALBRITTON DR. SUITE 7 Kennesaw, GA 30152
• Product Code: LXM
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-05-11
• Decision Date: 2000-08-04