Smart Correction System (HA Half Pins)— 510(k) K231461

Substantially Equivalent

Wishbone Medical, Inc.

FDA 510(k) clearance K231461 for Smart Correction System (HA Half Pins), Substantially Equivalent on 2023-06-16. Applicant: Wishbone Medical, Inc..

Clearance details

Applicant: Wishbone Medical, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2023-05-19
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.