SFX SNAP-FIT CROSS CONNECTOR

Orthosis, Spondylolisthesis Spinal Fixation

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Sfx Snap-fit Cross Connector.

Pre-market Notification Details

• Device ID: K062196
• 510k Number: K062196
• Device Name: SFX SNAP-FIT CROSS CONNECTOR
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Mary Gray
• Correspondent: Mary Gray; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: MNH
• Subsequent Product Code: KWP
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-01
• Decision Date: 2006-09-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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