INNESIS PEEK CERVICAL CAGE— 510(k) K132483

Name: FDA 510(k) clearance K132483
Creator: U.S. Food and Drug Administration
Published: 2014-04-02

Substantially Equivalent

Bk Meditech, Co., Ltd.

FDA 510(k) clearance K132483 for INNESIS PEEK CERVICAL CAGE, Substantially Equivalent on 2014-04-02. Applicant: Bk Meditech, Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bk Meditech, Co., Ltd.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-08-08
Decision date: 2014-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, 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 Bk Meditech, Co., Ltd.

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K200981 — Mega Plus MIS Spine System2020-08-11
K183080 — Mega Plus Spine System2018-12-10
K173180 — Mega Plus Spine System2018-03-15
K140577 — INNESIS PEEK TL CAGE2014-10-01
K120464 — INNESIS PEEK CAGE2013-01-18

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.