PASS ANTERIOR SPINAL SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MEDICREA TECHNOLOGIES

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

Pre-market Notification Details

• Device ID: K102406
• 510k Number: K102406
• Device Name: PASS ANTERIOR SPINAL SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• 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: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-24
• Decision Date: 2011-08-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03613720187578	K102406	000
03613720188193	K102406	000
03613720188209	K102406	000
03613720188216	K102406	000
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03613720187585	K102406	000
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03613720188476	K102406	000
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03613720188353	K102406	000
03613720188360	K102406	000
03613720188384	K102406	000
03613720188391	K102406	000
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