DuoHex CH Cannulated Hammertoe System— 510(k) K200840
Substantially EquivalentNextremity Solutions, Inc.
FDA 510(k) clearance K200840 for DuoHex CH Cannulated Hammertoe System, Substantially Equivalent on 2020-06-26. Applicant: Nextremity Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Nextremity Solutions, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HWC
view allMore clearances from Nextremity Solutions, Inc.
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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 →
Recalls naming K200840
K-number listed on FDA's recall record- Z-0739-2022 — Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
- Z-0740-2022 — Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200840.
Data sourced from openFDA. This site is unofficial and independent of the FDA.