WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM

Appliance, Fixation, Spinal Interlaminal

WARSAW ORTHOPEDIC, INC.

The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Warsaw Orthopedic Tsr Cross Link System.

Pre-market Notification Details

• Device ID: K870830
• 510k Number: K870830
• Device Name: WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580
• Contact: James Ritter
• Correspondent: James Ritter; WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-03-03
• Decision Date: 1987-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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