SYNTHES VECTRA-ONE SYSTEM— 510(k) K071667

Name: FDA 510(k) clearance K071667
Creator: U.S. Food and Drug Administration
Published: 2007-11-30

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K071667 for SYNTHES VECTRA-ONE SYSTEM, Substantially Equivalent on 2007-11-30. Applicant: Synthes Spine. Device class: 2.

Clearance details

Applicant: Synthes Spine
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2007-06-19
Decision date: 2007-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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 →

Recalls naming K071667

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071667.

Data sourced from openFDA. This site is unofficial and independent of the FDA.