J.B.S. CERVICAL SPINE SYSTEM— 510(k) K942432

Name: FDA 510(k) clearance K942432
Creator: U.S. Food and Drug Administration
Published: 1995-07-11

Substantially Equivalent for Some Indications

J.B.S., S.A.

FDA 510(k) clearance K942432 for J.B.S. CERVICAL SPINE SYSTEM, Substantially Equivalent for Some Indications on 1995-07-11. Applicant: J.B.S., S.A.. Device class: 2.

Clearance details

Applicant: J.B.S., S.A.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1994-05-20
Decision date: 1995-07-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

view all

K143278 — LnK Posterior Cervical Fixation System2015-07-29
K150753 — OASYS System2015-06-09
K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

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

view all

K962757 — J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP1996-09-25
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

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.