ChoiceSpine Stealth Cervical Spacer System— 510(k) K183397

Name: FDA 510(k) clearance K183397
Creator: U.S. Food and Drug Administration
Published: 2019-03-06

Substantially Equivalent

Choicespine, LP

FDA 510(k) clearance K183397 for ChoiceSpine Stealth Cervical Spacer System, Substantially Equivalent on 2019-03-06. Applicant: Choicespine, LP. Device class: 2.

Clearance details

Applicant: Choicespine, LP
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-12-07
Decision date: 2019-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Choicespine, LP

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K190227 — Boomerang Anterior Cervical Plate System2019-05-01
K182721 — Choice Spine Navigation System2019-01-08
K183214 — Raven Lumbar Plate System2019-01-03
K180519 — HARRIER-SA Lumbar Interbody System2018-05-16
K172816 — TiGer Shark System2018-01-26

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.