STERISPINE PS

Thoracolumbosacral Pedicle Screw System

SAFE ORTHOPAEDICS

The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine Ps.

Pre-market Notification Details

• Device ID: K140802
• 510k Number: K140802
• Device Name: STERISPINE PS
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SAFE ORTHOPAEDICS PARC DES BELLEVUES- ALLEE R LUXEMBOURG-BAT CALIFORNIE Eragny Sur Oise, FR 95610
• Contact: Pierre Dumouchel
• Correspondent: Pierre Dumouchel; SAFE ORTHOPAEDICS PARC DES BELLEVUES- ALLEE R LUXEMBOURG-BAT CALIFORNIE Eragny Sur Oise, FR 95610
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-31
• Decision Date: 2014-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760219912019	K140802	000
03760219919353	K140802	000
03760219919360	K140802	000
03760219919377	K140802	000
03760219919384	K140802	000
03760219919391	K140802	000
03760219919407	K140802	000
03760219919414	K140802	000
03760219919421	K140802	000
03760219919438	K140802	000
03760219919445	K140802	000
03760219919452	K140802	000
03760219919469	K140802	000
03760219919346	K140802	000
03760219919339	K140802	000
03760219919322	K140802	000
03760219912033	K140802	000
03760219912118	K140802	000
03760219912217	K140802	000
03760219913627	K140802	000
03760219913634	K140802	000
03760219913665	K140802	000
03760219919261	K140802	000
03760219919278	K140802	000
03760219919285	K140802	000
03760219919292	K140802	000
03760219919308	K140802	000
03760219919315	K140802	000
03760219919483	K140802	000
03760219919490	K140802	000
03760219919506	K140802	000
03760219912101	K140802	000
03760219912125	K140802	000
03760219912149	K140802	000
03760219912163	K140802	000
03760219912187	K140802	000
03760219912200	K140802	000
03760219912224	K140802	000
03760219912248	K140802	000
03760219912262	K140802	000
03760219912286	K140802	000
03760219912651	K140802	000
03760219912675	K140802	000
03760219912088	K140802	000
03760219912064	K140802	000
03760219912040	K140802	000
03760219919513	K140802	000
03760219919520	K140802	000
03760219919537	K140802	000
03760219919599	K140802	000
03760219919605	K140802	000
03760219919612	K140802	000
03760219919629	K140802	000
03760219919636	K140802	000
03760219911135	K140802	000
03760219911197	K140802	000
03760219912002	K140802	000
03760219912026	K140802	000
03760219912699	K140802	000