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: K170528
• 510k Number: K170528
• Device Name: Sterispine™ PS
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SAFE ORTHOPAEDICS PARC DES BELLEVUES Allee R. Luxembourg-Bat.Califonie Eragny Sur Oise, FR 95610
• Contact: Pierre Dumouchel
• Correspondent: Pierre Dumouchel; SAFE ORTHOPAEDICS PARC DES BELLEVUES Allée Rosa Luxembourg – Batiment Le Californie Eragny Sur Oise, FR 95610
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-22
• Decision Date: 2017-03-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760219910435	K170528	000
03760219910787	K170528	000
03760219910794	K170528	000
03760219910800	K170528	000
03760219910817	K170528	000
03760219911463	K170528	000
03760219911487	K170528	000
03760219911500	K170528	000
03760219911524	K170528	000
03760219911548	K170528	000
03760219911586	K170528	000
03760219911609	K170528	000
03760219911647	K170528	000
03760219910770	K170528	000
03760219910756	K170528	000
03760219910725	K170528	000
03760219910442	K170528	000
03760219910466	K170528	000
03760219910480	K170528	000
03760219910510	K170528	000
03760219910527	K170528	000
03760219910534	K170528	000
03760219910558	K170528	000
03760219910589	K170528	000
03760219910596	K170528	000
03760219910640	K170528	000
03760219910688	K170528	000
03760219910718	K170528	000
03760219911661	K170528	000
03760219911746	K170528	000
03760219911760	K170528	000
03760219913726	K170528	000
03760219913733	K170528	000
03760219913740	K170528	000
03760219913764	K170528	000
03760219913771	K170528	000
03760219913788	K170528	000
03760219913795	K170528	000
03760219913801	K170528	000
03760219913825	K170528	000
03760219913832	K170528	000
03760219913849	K170528	000
03760219913856	K170528	000
03760219913719	K170528	000
03760219913702	K170528	000
03760219912293	K170528	000
03760219911784	K170528	000
03760219911807	K170528	000
03760219912057	K170528	000
03760219912071	K170528	000
03760219912095	K170528	000
03760219912132	K170528	000
03760219912156	K170528	000
03760219912170	K170528	000
03760219912194	K170528	000
03760219912231	K170528	000
03760219912255	K170528	000
03760219912279	K170528	000
03760219913863	K170528	000