HAcancellous PEEK-C Porous HA PEEK Cervical IBF System— 510(k) K220875

Name: FDA 510(k) clearance K220875
Creator: U.S. Food and Drug Administration
Published: 2022-08-26

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K220875 for HAcancellous PEEK-C Porous HA PEEK Cervical IBF System, Substantially Equivalent on 2022-08-26. Applicant: Innovasis, Inc.. Device class: 2.

Clearance details

Applicant: Innovasis, Inc.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-03-25
Decision date: 2022-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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 Innovasis, Inc.

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K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)2025-07-23
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K241276 — Vector Pedicle Screw System2024-05-20
K231899 — HAtetracell-C Titanium Cervical IBF System2023-10-17
K223511 — Excella Navigation Instruments2023-05-02

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.