Atlas FDA

Infinity™ OCT System, PASS OCT® Spinal System

FDA 510(k) clearance K210449 · decided 2021-03-18

Clearance details

K-number
K210449
Device name
Infinity™ OCT System, PASS OCT® Spinal System
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2021-02-16
Decision date
2021-03-18
Days to decision
30 days
Clearance type
Special
Product code
NKG
Device class
2
Regulation number
888.3075
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
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (K253195)ZheJiang Decans Medical Devices Co., Ltd.2026-06-02
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (K254045)CarboFix Orthopedics , Ltd.2026-03-16
Infinity™ OCT System (K254165)Medtronic Sofamor Danek USA, Inc.2026-01-21
CMORE® CT System; CMORE® CT System Navigated Instruments (K252327)Icotec AG2025-11-12
Infinity™ OCT System (K253129)Medtronic Sofamor Danek USA, Inc.2025-10-24
ANAX™ OCT Spinal System (K251725)Cg Medtech Co., Ltd.2025-06-25
Sovereign Posterior Cervical System (K250866)Met One Technologies, LLC2025-05-20
Freedom Posterior Cervical Screws (K242674)Signature Orthopaedics Pty, Ltd.2025-05-13
Virage® OCT Spinal Fixation System (K250332)Highridge Medical, LLC2025-04-04
EUROPA™ Posterior Cervical Fusion System (K242516)MiRus, LLC2024-11-19
CarboClear® Posterior Cervical Screw System (K233989)CarboFix Orthopedics , Ltd.2024-03-27
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (K231850)Globus Medical, Inc.2024-03-14

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