Atlas FDA

Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System

FDA 510(k) clearance K211710 · decided 2021-07-30

Clearance details

K-number
K211710
Device name
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
Applicant
Orthofix, Inc.
Decision
Substantially Equivalent
Date received
2021-06-03
Decision date
2021-07-30
Days to decision
57 days
Clearance type
Traditional
Product code
NKG
Device class
2
Regulation number
888.3075
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Lewisville, TX, 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
CervicalStim® (P030034/S017)Orthofix, Inc.2022-06-14
PhysioStim®, SpinalStim® (P850007/S046)Orthofix, Inc.2022-06-14
SpinalStim (P850007/S044)Orthofix, Inc.2020-03-27
CervicalStim (P030034/S015)Orthofix, Inc.2019-10-08
PhysioStim and SpinalStim (P850007/S043)Orthofix, Inc.2019-10-08
SpinalStim (P850007/S042)Orthofix, Inc.2019-07-03
PhysioStim and SpinalStim (P850007/S041)Orthofix, Inc.2019-06-18
CervicalStim (P030034/S014)Orthofix, Inc.2019-06-18