SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT

Orthosis, Spinal Pedicle Fixation

SPINEVISION, S.A.

The following data is part of a premarket notification filed by Spinevision, S.a. with the FDA for Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.l.i.s. Polyaxial Pedicle Screw Fixat.

Pre-market Notification Details

• Device ID: K130302
• 510k Number: K130302
• Device Name: SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: SPINEVISION, S.A. ANTONY PARC II - 10 PLACE DU GENERAL DE GAULLE CS 70001 Antony Cedex, FR 92184
• Contact: Helene Plas
• Correspondent: Helene Plas; SPINEVISION, S.A. ANTONY PARC II - 10 PLACE DU GENERAL DE GAULLE CS 70001 Antony Cedex, FR 92184
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-07
• Decision Date: 2013-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03663136007168	K130302	000
03663136006574	K130302	000
03663136006635	K130302	000
03663136006727	K130302	000
03663136006741	K130302	000
03663136006826	K130302	000
03663136006833	K130302	000
03663136006840	K130302	000
03663136006857	K130302	000
03663136007144	K130302	000
03663136007175	K130302	000
03663136007182	K130302	000
03663136007205	K130302	000
03663136006482	K130302	000
03663136002576	K130302	000
03663136007359	K130302	000
03663136007328	K130302	000
03663136006499	K130302	000
03663136006819	K130302	000
03663136007151	K130302	000
03663136007212	K130302	000
03663136007397	K130302	000
03663136007403	K130302	000
03663136002538	K130302	000
03663136002545	K130302	000
03663136002552	K130302	000
03663136006734	K130302	000
03663136007199	K130302	000
03663136007229	K130302	000
03663136007236	K130302	000
03663136007243	K130302	000
03663136020099	K130302	000
03663136020105	K130302	000
03663136020112	K130302	000
03663136020129	K130302	000
03663136020136	K130302	000
03663136020143	K130302	000
03663136020150	K130302	000
03663136020167	K130302	000
03663136020174	K130302	000
03663136007274	K130302	000
03663136007335	K130302	000
03663136007366	K130302	000
03663136007465	K130302	000
03663136007458	K130302	000
03663136007441	K130302	000
03663136007250	K130302	000
03663136007267	K130302	000
03663136007281	K130302	000
03663136007298	K130302	000
03663136007304	K130302	000
03663136007311	K130302	000
03663136007342	K130302	000
03663136007373	K130302	000
03663136007380	K130302	000
03663136007410	K130302	000
03663136007427	K130302	000
03663136007434	K130302	000
03663136020181	K130302	000