DYNESYS SPINAL SYSTEM— 510(k) K031511

Unknown

Centerpulse Spine-Tech, Inc.

FDA 510(k) clearance K031511 for DYNESYS SPINAL SYSTEM, Unknown on 2004-03-05. Applicant: Centerpulse Spine-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Centerpulse Spine-Tech, Inc.
Product code: Code NQP
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2003-05-14
Decision date: 2004-03-05
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Centerpulse Spine-Tech, Inc.

K033679 — COPSIOS BONE VOID FILLER (BVF)2004-07-07
K022615 — CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR2002-10-29
K022344 — TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM2002-09-24

Recalls naming K031511

K-number listed on FDA's recall record

Z-0236-2013 — Dynesys¿ Set screw M6Class II·Terminated·Zimmer, Inc.·20120904
Z-0237-2013 — Dynesys¿ Universal spacer 6-45Class II·Terminated·Zimmer, Inc.·20120904
Z-0238-2013 — Dynesys¿ L.I.S. Stabilizing cord Rx, SterileClass II·Terminated·Zimmer, Inc.·20120904
Z-0239-2013 — Dynesys¿ Revision + set screwClass II·Terminated·Zimmer, Inc.·20120904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031511.

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