EOS SPINAL SYSTEM— 510(k) K082509

Name: FDA 510(k) clearance K082509
Creator: U.S. Food and Drug Administration
Published: 2008-12-15

Substantially Equivalent

Korea Bone Bank Co., Ltd.

FDA 510(k) clearance K082509 for EOS SPINAL SYSTEM, Substantially Equivalent on 2008-12-15. Applicant: Korea Bone Bank Co., Ltd.. Device class: 2.

Clearance details

Applicant: Korea Bone Bank Co., Ltd.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-08-29
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

More clearances from Korea Bone Bank Co., Ltd.

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K120538 — PALLS M SPINAL SYSTEM2012-03-23
K102574 — PALLA M SPINAL SYSTEM2011-03-07

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.