ROPER-TUKE ELBOW— 510(k) K873660

Substantially Equivalent for Some Indications

Orthopedic Systems, Inc.

FDA 510(k) clearance K873660 for ROPER-TUKE ELBOW, Substantially Equivalent for Some Indications on 1988-01-06. Applicant: Orthopedic Systems, Inc..

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code JDB
Advisory panel: Orthopedic
Date received: 1987-09-10
Decision date: 1988-01-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.