OIC Cervical PEEK Spacer
K-Number: K160222 · 2016-12-07
ApplicantThe Orthopaedic Implant Company
Decision Date2016-12-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OIC Cervical PEEK Spacer is a medical device manufactured by The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2016-12-07 under approval number K160222. 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 OIC Cervical PEEK Spacer?
OIC Cervical PEEK Spacer is a medical device that received FDA 510(k) clearance on 2016-12-07. It is manufactured by The Orthopaedic Implant Company. The 510(k) number is K160222.
When was OIC Cervical PEEK Spacer approved by the FDA?
OIC Cervical PEEK Spacer received FDA 510(k) clearance on 2016-12-07, under approval number K160222.
What company makes OIC Cervical PEEK Spacer?
OIC Cervical PEEK Spacer is manufactured by The Orthopaedic Implant Company.
What is the FDA product code for OIC Cervical PEEK Spacer?
The FDA product code for OIC Cervical PEEK Spacer is ODP.
Other Devices by The Orthopaedic Implant Company
Related Devices (Code: ODP)
K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.
K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education
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
K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated
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.