ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)— 510(k) K130147
Substantially EquivalentSmall Bone Innovations, Inc.
FDA 510(k) clearance K130147 for ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL), Substantially Equivalent on 2013-05-03. Applicant: Small Bone Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Small Bone Innovations, 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
- Special
- Location
- Morrisville, PA, US
Recent devices under product code HSB
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- 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 Small Bone Innovations, Inc.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.