AEQUALIS HUMERAL NAIL SYSTEM— 510(k) K082754
Substantially EquivalentTornier
FDA 510(k) clearance K082754 for AEQUALIS HUMERAL NAIL SYSTEM, Substantially Equivalent on 2009-01-27. Applicant: Tornier. Device class: 2.
Clearance details
- Applicant
- Tornier
- 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
- Warsaw, IN, 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 Tornier
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 →
Recalls naming K082754
K-number listed on FDA's recall record- Z-1757-2018 — AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
- Z-2315-2015 — Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082754.
Data sourced from openFDA. This site is unofficial and independent of the FDA.