TI-FRAME— 510(k) K934860

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K934860 for TI-FRAME, Substantially Equivalent on 1994-06-03. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1993-10-12
Decision date: 1994-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.