CD HORIZON Spinal System Instruments For Use With MAZOR X Stealth Edition

Orthopedic Stereotaxic Instrument

Medtronic Sofamor Danek USA, Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon Spinal System Instruments For Use With Mazor X Stealth Edition.

Pre-market Notification Details

• Device ID: K182121
• 510k Number: K182121
• Device Name: CD HORIZON Spinal System Instruments For Use With MAZOR X Stealth Edition
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Erikka Edwardsen
• Correspondent: Erikka Edwardsen; Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-06
• Decision Date: 2018-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000516192	K182121	000
00763000023645	K182121	000
00763000023638	K182121	000
00763000023621	K182121	000
00763000011369	K182121	000
00763000011352	K182121	000
00763000011345	K182121	000
00763000011338	K182121	000
00763000011321	K182121	000
00763000023652	K182121	000
00763000023669	K182121	000
00763000023744	K182121	000
00763000023737	K182121	000
00763000023720	K182121	000
00763000023713	K182121	000
00763000023706	K182121	000
00763000023690	K182121	000
00763000023683	K182121	000
00763000023676	K182121	000
00763000011314	K182121	000
00763000011307	K182121	000
00763000306809	K182121	000
00763000374105	K182121	000
00763000374099	K182121	000
00763000374082	K182121	000
00763000374075	K182121	000
00763000516222	K182121	000
00763000516215	K182121	000
00763000516208	K182121	000
00763000306816	K182121	000
00763000306823	K182121	000
00763000011291	K182121	000
00763000011284	K182121	000
00763000011277	K182121	000
00763000011260	K182121	000
00763000011253	K182121	000
00763000011246	K182121	000
00763000011239	K182121	000
00763000011222	K182121	000
00763000023751	K182121	000
00763000023768	K182121	000
00763000140359	K182121	000
00763000140311	K182121	000
00763000092511	K182121	000
00763000092504	K182121	000
00763000082420	K182121	000
00763000082413	K182121	000
00763000082406	K182121	000
00763000082390	K182121	000
00763000140366	K182121	000
00763000140373	K182121	000
00763000141479	K182121	000
00763000141462	K182121	000
00763000140489	K182121	000
00763000140465	K182121	000
00763000140434	K182121	000
00763000140427	K182121	000
00763000140410	K182121	000
00763000140380	K182121	000
00763000082383	K182121	000
00763000082376	K182121	000
00763000082185	K182121	000
00763000082178	K182121	000
00763000082154	K182121	000
00763000082109	K182121	000
00763000082093	K182121	000
00763000082086	K182121	000
00763000023782	K182121	000
00763000023775	K182121	000
00763000082192	K182121	000
00763000082239	K182121	000
00763000082314	K182121	000
00763000082307	K182121	000
00763000082291	K182121	000
00763000082284	K182121	000
00763000082277	K182121	000
00763000082260	K182121	000
00763000082253	K182121	000
00763000082246	K182121	000
00763000159603	K182121	000