Aster— 510(k) K254182
Substantially EquivalentOsteonic Co., Ltd.
FDA 510(k) clearance K254182 for Aster, Substantially Equivalent on 2026-02-26. Applicant: Osteonic Co., Ltd.. Device class: 2.
Summary
Osteonic filed a device named only Aster under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). The name gives nothing further, and the record has no other description.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Osteonic filed from Seoul, South Korea. The substantially equivalent decision came 65 calendar days after receipt (December 23, 2025 to February 26, 2026).
Clearance details
- Applicant
- Osteonic Co., Ltd.
- Product code
- Product code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code KWQ
view allMore clearances from Osteonic Co., Ltd.
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . 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.