J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP— 510(k) K962757

Name: FDA 510(k) clearance K962757
Creator: U.S. Food and Drug Administration
Published: 1996-09-25

Substantially Equivalent

J.B.S., S.A.

FDA 510(k) clearance K962757 for J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP, Substantially Equivalent on 1996-09-25. Applicant: J.B.S., S.A.. Device class: 2.

Clearance details

Applicant: J.B.S., S.A.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1996-07-16
Decision date: 1996-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasenton, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from J.B.S., S.A.

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K955864 — J.B. S. C1-C2 CLAMP1996-03-15
K953881 — SPINE SYSTEM SACRAL PLATE1996-02-21
K953599 — CLAMP ASSEMBLY1995-12-19
K952298 — SPINAL PEDICLE SCREW, FIXATION, APPLIANCE1995-12-13
K942432 — J.B.S. CERVICAL SPINE SYSTEM1995-07-11

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.