SPINE SYSTEM SACRAL PLATE— 510(k) K953881

Substantially Equivalent for Some Indications

J.B.S., S.A.

FDA 510(k) clearance K953881 for SPINE SYSTEM SACRAL PLATE, Substantially Equivalent for Some Indications on 1996-02-21. Applicant: J.B.S., S.A..

Clearance details

Applicant: J.B.S., S.A.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1995-08-18
Decision date: 1996-02-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Pleasenton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.