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510(k) K133214

BLACKBIRD SPINAL SYSTEM by Choicespine, LP — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2014
Date Received
October 18, 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

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  • K180519 — HARRIER-SA™ Lumbar Interbody System (May 16, 2018)
  • K172816 — TiGer Shark™ System (January 26, 2018)
  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)
  • K171489 — Acapella Cervical Spacer System (October 23, 2017)
  • K171686 — Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (September 15, 2017)

Other clearances for product code KWP

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  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)