FIX-C PEEK Anterior Cervical Interbody System
K-Number: K212266 · 2021-12-21
ApplicantJeil Medical Corporation
Decision Date2021-12-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FIX-C PEEK Anterior Cervical Interbody System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2021-12-21 under approval number K212266. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FIX-C PEEK Anterior Cervical Interbody System?
FIX-C PEEK Anterior Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Jeil Medical Corporation. The 510(k) number is K212266.
When was FIX-C PEEK Anterior Cervical Interbody System approved by the FDA?
FIX-C PEEK Anterior Cervical Interbody System received FDA 510(k) clearance on 2021-12-21, under approval number K212266.
What company makes FIX-C PEEK Anterior Cervical Interbody System?
FIX-C PEEK Anterior Cervical Interbody System is manufactured by Jeil Medical Corporation.
What is the FDA product code for FIX-C PEEK Anterior Cervical Interbody System?
The FDA product code for FIX-C PEEK Anterior Cervical Interbody System is ODP.
Related Clinical Trials
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
RECRUITING
NCT06462729
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
RECRUITING
NCT07606196
The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases
COMPLETED
NCT01630707
Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack
COMPLETED
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
Other Devices by Jeil Medical Corporation
Related Devices (Code: ODP)
K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.
K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education
K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company
K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.
K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd.
K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.