J.B. S. C1-C2 CLAMP— 510(k) K955864

Substantially Equivalent

J.B.S., S.A.

FDA 510(k) clearance K955864 for J.B. S. C1-C2 CLAMP, Substantially Equivalent on 1996-03-15. Applicant: J.B.S., S.A..

Clearance details

Applicant: J.B.S., S.A.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1995-12-27
Decision date: 1996-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mill Valley, CA, US

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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.