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510(k) K093438

PARADIGM INTERSPINOUS FUSION PLATE by Paradigm Spine, LLC — Product Code KWP

K093438 is an FDA 510(k) premarket notification submitted by Paradigm Spine, LLC for the device "PARADIGM INTERSPINOUS FUSION PLATE". The FDA issued a decision of Substantially Equivalent on October 6, 2010. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Paradigm Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2010
Date Received
November 4, 2009
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

Other clearances by Paradigm Spine, LLC

  • K213493 — Fortilink with TiPlus Technology (January 27, 2022)
  • K201453 — Fortilink Cages with TiPlus Technology (October 7, 2020)
  • K201704 — CoFix System (August 4, 2020)
  • K153302 — coflex-IF (September 8, 2016)
  • K120491 — DSS STABILIZATION SYSTEM-RIGID (May 9, 2012)
  • K112595 — COFLEX-F (February 13, 2012)
  • K113625 — DSS STABILIZATION SYSTEM (January 10, 2012)
  • K101083 — DSS STABILIZATION SYSTEM (July 2, 2010)
  • K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM (August 3, 2009)
  • K090099 — DSS STABILIZATION SYSTEM (June 19, 2009)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • 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)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources