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510(k) K142460

EXPEDIUM Spine System/Synapse System by Johnson and Johnson — Product Code KWP

K142460 is an FDA 510(k) premarket notification submitted by Johnson and Johnson for the device "EXPEDIUM Spine System/Synapse System". The FDA issued a decision of Substantially Equivalent on October 1, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Johnson and Johnson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2014
Date Received
September 2, 2014
Clearance Type
Special
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 Johnson and Johnson

  • K113273 — SPOTLIGHT ACCESS SYSTEM (January 27, 2012)
  • K112913 — SPOTLIGHT ACCESS SYSTEM (December 16, 2011)
  • K113348 — COUGAR SYSTEM (December 13, 2011)
  • K110551 — EXPEDIUM SPINE SYSTEM (October 26, 2011)
  • K110694 — CONCORDE BULLET SPINAL SYSTEM (October 11, 2011)
  • K111571 — VIPER SYSTEMS (July 6, 2011)
  • K110454 — COUGAR LS LATERAL CAGE SYSTEM (May 13, 2011)
  • K103743 — CONCORDE CURVE SYSTEM (March 17, 2011)
  • K103488 — CONCORDE BULLET CAGE SYSTEM (March 2, 2011)
  • K103490 — EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM (February 17, 2011)

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