CLICK'X

Orthosis, Spondylolisthesis Spinal Fixation

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Click'x.

Pre-market Notification Details

• Device ID: K992739
• 510k Number: K992739
• Device Name: CLICK'X
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301
• Contact: Jonathan M Gilbert
• Correspondent: Jonathan M Gilbert; SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-16
• Decision Date: 2000-02-08
• Summary: summary