LINK SADDLE PROTHESIS— 510(k) K951355

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K951355 for LINK SADDLE PROTHESIS, Substantially Equivalent on 1995-05-25. Applicant: Turnkey Intergration USA, Inc..

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1995-03-08
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.