Prophecy Surgical Planning System— 510(k) K241999

Substantially Equivalent

Wright Medical Technology, Inc. (Stryker)

FDA 510(k) clearance K241999 for Prophecy Surgical Planning System, Substantially Equivalent on 2024-11-01. Applicant: Wright Medical Technology, Inc. (Stryker).

Clearance details

Applicant
Wright Medical Technology, Inc. (Stryker)
Product code
Code HSN
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Memphis, TN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HSN

product code HSN
Death
3
Injury
4,711
Total
4,714

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.