OXFORD ANKLE FUSION NAIL(AFN) SYSTEM— 510(k) K121575
Substantially EquivalentOrtho Solutions Limited
FDA 510(k) clearance K121575 for OXFORD ANKLE FUSION NAIL(AFN) SYSTEM, Substantially Equivalent on 2012-09-14. Applicant: Ortho Solutions Limited. Device class: 2.
Clearance details
- Applicant
- Ortho Solutions Limited
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Prior Lake, MN, US
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Ortho Solutions Limited
view all- K141784 — ORTHO SOLUTIONS ULTOS PLATING SYSTEM
- K120360 — ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
- K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
- K110895 — ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
- K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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 K121575
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121575.
Data sourced from openFDA. This site is unofficial and independent of the FDA.