ROPER-TUKE ELBOW— 510(k) K873660

Name: FDA 510(k) clearance K873660
Creator: U.S. Food and Drug Administration
Published: 1988-01-06

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.. Device class: 2.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code JDB
Device class: Class 2
Regulation: 21 CFR 888.3160
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 ↗

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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.