Coveris Cervical Cage System— 510(k) K170550

Name: FDA 510(k) clearance K170550
Creator: U.S. Food and Drug Administration
Published: 2017-07-13

Substantially Equivalent

Camber Spine Technologies

FDA 510(k) clearance K170550 for Coveris Cervical Cage System, Substantially Equivalent on 2017-07-13. Applicant: Camber Spine Technologies. Device class: 2.

Clearance details

Applicant: Camber Spine Technologies
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2017-02-24
Decision date: 2017-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Camber Spine Technologies

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K234077 — SPIRA® Anterior Lumbar Spacers2024-07-12
K233972 — Camber Sacroiliac (SI) Fixation System2024-02-27
K230942 — SPIRA® Posterior Lumbar Spacers2023-07-11
K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)2023-03-30
K223837 — SPIRA®-C Integrated Fixation System2023-03-22

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.