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510(k) K142558

Caspian OCT/MESA Mini/DENALI Mini Spinal System by K2m — Product Code KWP

K142558 is an FDA 510(k) premarket notification submitted by K2m for the device "Caspian OCT/MESA Mini/DENALI Mini Spinal System". The FDA issued a decision of Substantially Equivalent on December 22, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. K2m has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2014
Date Received
September 11, 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 K2m

  • K260546 — Q Pedicle Instruments (March 17, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K202528 — Cannulated Power Driver Attachment (October 26, 2020)
  • K201006 — K2M Navigation Instruments (August 7, 2020)
  • K193203 — MOJAVE Expandable Interbody System (February 18, 2020)
  • K193129 — Yukon OCT Spinal System (February 7, 2020)
  • K192911 — Brainlab Compatible K2M Navigation Instruments (November 14, 2019)
  • K190179 — SAHARA Stabilization System (October 3, 2019)

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)
  • K140734 — NEXTGEN ALTIUS OCT SYSTEM (December 15, 2014)

FDA data resources