PASS LP Spinal System

Thoracolumbosacral Pedicle Screw System

MEDICREA INTERNATIONAL S.A.

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

Pre-market Notification Details

• Device ID: K153413
• 510k Number: K153413
• Device Name: PASS LP Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON Neyron, FR 01700
• Contact: David Ryan
• Correspondent: David Ryan; MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON Neyron, FR 01700
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-25
• Decision Date: 2016-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03613720268208	K153413	000
03613720295464	K153413	000
03613720295457	K153413	000
03613720295440	K153413	000
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