FLEXFUSION (TM) FIXATION IMPLANT— 510(k) K110445
Substantially EquivalentNextremity Solutions, LLC
FDA 510(k) clearance K110445 for FLEXFUSION (TM) FIXATION IMPLANT, Substantially Equivalent on 2011-03-17. Applicant: Nextremity Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Nextremity Solutions, LLC
- 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
- Colts Neck, NJ, US
Recent devices under product code HWC
view allMore clearances from Nextremity Solutions, LLC
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 K110445
K-number listed on FDA's recall record- Z-0910-2022 — Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
- Z-0911-2022 — Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
- Z-0912-2022 — Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
- Z-0913-2022 — Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
- Z-0914-2022 — Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
- Z-1458-2020 — Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110445.
Data sourced from openFDA. This site is unofficial and independent of the FDA.