ChoiceSpine Stealth Cervical Spacer System
K-Number: K183397 · 2019-03-06
ApplicantChoicespine, LP
Decision Date2019-03-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ChoiceSpine Stealth Cervical Spacer System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2019-03-06 under approval number K183397. 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 ChoiceSpine Stealth Cervical Spacer System?
ChoiceSpine Stealth Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2019-03-06. It is manufactured by Choicespine, LP. The 510(k) number is K183397.
When was ChoiceSpine Stealth Cervical Spacer System approved by the FDA?
ChoiceSpine Stealth Cervical Spacer System received FDA 510(k) clearance on 2019-03-06, under approval number K183397.
What company makes ChoiceSpine Stealth Cervical Spacer System?
ChoiceSpine Stealth Cervical Spacer System is manufactured by Choicespine, LP.
What is the FDA product code for ChoiceSpine Stealth Cervical Spacer System?
The FDA product code for ChoiceSpine Stealth Cervical Spacer System is ODP.
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Other Devices by Choicespine, LP
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)
K160775Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
K153107Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
K171489Acapella Cervical Spacer System
K170821ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System
K170942The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
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.