Dyflex-II— 510(k) K212700
Substantially EquivalentTaeyeon Medical Co., Ltd.
FDA 510(k) clearance K212700 for Dyflex-II, Substantially Equivalent on 2022-11-15. Applicant: Taeyeon Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Taeyeon Medical Co., Ltd.
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wonju-Si, KR
Recent devices under product code NKB
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More clearances from Taeyeon Medical Co., Ltd.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.