Precice Max System and Precice Ankle Salvage System— 510(k) K261651
Substantially EquivalentNuVasive Specialized Orthopedics
FDA 510(k) clearance K261651 for Precice Max System and Precice Ankle Salvage System, Substantially Equivalent on 2026-06-18. Applicant: NuVasive Specialized Orthopedics. Device class: 2.
Clearance details
- Applicant
- NuVasive Specialized Orthopedics
- 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
- Audubon, PA, 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)
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
- K260146 — FITBONE® TRANSPORT AND LENGTHENING 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.