TRACER HIP PINNING SYSTEM— 510(k) K884406

Substantially Equivalent

De Medica Mfg., Inc.

FDA 510(k) clearance K884406 for TRACER HIP PINNING SYSTEM, Substantially Equivalent on 1988-11-28. Applicant: De Medica Mfg., Inc..

Clearance details

Applicant: De Medica Mfg., Inc.
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 1988-10-19
Decision date: 1988-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Paula, CA, US

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Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.