Atlas FDA

CD Horizon Spinal System

FDA 510(k) clearance K202771 · decided 2020-10-19

Clearance details

K-number
K202771
Device name
CD Horizon Spinal System
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2020-09-21
Decision date
2020-10-19
Days to decision
28 days
Clearance type
Special
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tiger 2 System (K253943)Zavation Medical Products, LLC2026-07-24
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (K260362)MANTIZ Co., Ltd.2026-07-24
Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (K261284)Alphatec Spine, Inc.2026-07-14
KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253802)S.M.A.I.O2026-07-01
“Socko” Vimax Spinal Fixation System (K253045)Socko Medical Co., Ltd.2026-06-17
ChanPin Pedicle Screw Spinal System (K251251)Chanpin Medtak Co., Ltd.2026-06-09
Varion Thoracolumbar Fixation System (K260989)Kyocera Medical Technologies Inc. (KMTI)2026-05-15
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739)Globus Medical, Inc.2026-05-07
AccelFix Spinal Fixation System (K261130)L&K BIOMED Co., Ltd.2026-05-05
PERLA® TL Posterior Thoraco-lumbar Fixation System (K253966)Spineart SA2026-05-01
LEO Spinal System (K252542)ZheJiang Decans Medical Devices Co., Ltd.2026-04-29
M.U.S.T. Pedicle Screw System - Extension (K253940)Medacta International S.A.2026-04-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13