SYNTHES CERVIFIX SYSTEM— 510(k) K991089

Name: FDA 510(k) clearance K991089
Creator: U.S. Food and Drug Administration
Published: 1999-08-27

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K991089 for SYNTHES CERVIFIX SYSTEM, Substantially Equivalent on 1999-08-27. Applicant: Synthes Spine. Device class: 2.

Clearance details

Applicant: Synthes Spine
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1999-03-31
Decision date: 1999-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWP

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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 Synthes Spine

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K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS2012-12-17
K120838 — SYNTHES MATRIX SYSTEM2012-07-31
K111048 — SYNTHES SCOUT TACK FIXATION2012-06-14
K120928 — SYNTHES MATRIX SYSTEM2012-05-18
K120571 — SYNTHES USS CONNECTOR2012-05-14

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.