ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)— 510(k) K010322
Substantially EquivalentOrthodyne, Inc.
FDA 510(k) clearance K010322 for ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR), Substantially Equivalent on 2001-05-02. Applicant: Orthodyne, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthodyne, Inc.
- 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
- Orlando, FL, 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
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 K010322
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 K010322.
Data sourced from openFDA. This site is unofficial and independent of the FDA.