Home / 510(k) Clearances / K132900

510(k) K132900

MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM by Intelligent Implant Systems, LLC — Product Code KWP

K132900 is an FDA 510(k) premarket notification submitted by Intelligent Implant Systems, LLC for the device "MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 25, 2013. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Intelligent Implant Systems, LLC has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 25, 2013
Date Received
Sep 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type
510(k)

Other clearances by Intelligent Implant Systems, LLC

  • K173935 — Mediant Anterior Cervical Plating System (Apr 16, 2018)
  • K163056 — Revolution™ Spinal Fixation System (Feb 24, 2017)
  • K160216 — Revolution Spinal Fixation System (Apr 22, 2016)
  • K142939 — Revolution Spinal Fixation System (Jan 13, 2015)
  • K121682 — ACTIVE SCREW BONE SCREW (Oct 4, 2012)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (Jul 29, 2015)
  • K150753 — OASYS System (Jun 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (Jun 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (Apr 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (Apr 28, 2015)
  • K142253 — SOLSTICE OCT System (Apr 23, 2015)
  • K150229 — SOLSTICE OCT System (Apr 7, 2015)
  • K143249 — SOLSTICE OCT System (Apr 7, 2015)
  • K142741 — OASYS System (Jan 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (Dec 22, 2014)

FDA data resources