PWB LUMBOSACRAL SPINE SYSTEM— 510(k) K920116

Substantially Equivalent for Some Indications

Cross Medical Products, Inc.

FDA 510(k) clearance K920116 for PWB LUMBOSACRAL SPINE SYSTEM, Substantially Equivalent for Some Indications on 1992-04-10. Applicant: Cross Medical Products, Inc..

Clearance details

Applicant: Cross Medical Products, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1992-01-13
Decision date: 1992-04-10
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Concord, CA, 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.