SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K081132

Name: FDA 510(k) clearance K081132
Creator: U.S. Food and Drug Administration
Published: 2008-07-14

Substantially Equivalent

Spine Smith Partners L.P.

FDA 510(k) clearance K081132 for SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2008-07-14. Applicant: Spine Smith Partners L.P.. Device class: 2.

Clearance details

Applicant: Spine Smith Partners L.P.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2008-04-21
Decision date: 2008-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Spine Smith Partners L.P.

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K122630 — IN:C2 SPINAL FIXATION SYSTEM2012-12-05
K122168 — VISUALIF CHALLENGING ACCESS PLATE2012-10-11
K102090 — SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM2010-09-30
K101085 — SPINESMITH CYNCH SPINAL SYSTEM2010-07-01
K090376 — SPINESMITH CYNCH SPINAL SYSTEM2009-04-01

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 →

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