ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS— 510(k) K896106

Substantially Equivalent for Some Indications

Richards Medical Co., Inc.

FDA 510(k) clearance K896106 for ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS, Substantially Equivalent for Some Indications on 1990-06-25. Applicant: Richards Medical Co., Inc..

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1989-10-20
Decision date: 1990-06-25
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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.