OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM— 510(k) K113123

Substantially Equivalent

The Orthopaedic Implant Company

FDA 510(k) clearance K113123 for OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM, Substantially Equivalent on 2012-01-12. Applicant: The Orthopaedic Implant Company.

Clearance details

Applicant: The Orthopaedic Implant Company
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2011-10-21
Decision date: 2012-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, 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.