4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage— 510(k) K190563

Name: FDA 510(k) clearance K190563
Creator: U.S. Food and Drug Administration
Published: 2019-09-18

Substantially Equivalent

Solco Biomedical Co., Ltd.

FDA 510(k) clearance K190563 for 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage, Substantially Equivalent on 2019-09-18. Applicant: Solco Biomedical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Solco Biomedical Co., Ltd.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2019-03-05
Decision date: 2019-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.