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.
Summary
NuVasive Specialized Orthopedics' clearance names the Precice Max System and the Precice Ankle Salvage System. The record lists one product code, HSB, intramedullary fixation rods and accessories.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
NuVasive filed from Audubon, Pennsylvania. Review took 30 calendar days (May 19 to June 18, 2026).
Clearance details
- Applicant
- NuVasive Specialized Orthopedics
- Product code
- Product 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 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.