MODIFICATION TO PASSMED SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

MEDICREA TECHNOLOGIES

The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Modification To Passmed Spinal System.

Pre-market Notification Details

• Device ID: K070530
• 510k Number: K070530
• Device Name: MODIFICATION TO PASSMED SPINAL SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681
• Contact: J.d. Webb
• Correspondent: J.d. Webb; MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681
• Product Code: MNH
• Subsequent Product Code: KWP
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-23
• Decision Date: 2007-10-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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