Home / 510(k) Clearances / K121725

510(k) K121725

PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM by Pioneer Surgical Technology, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2012
Date Received
June 12, 2012
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 Pioneer Surgical Technology, Inc.

  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K222493 — CODA™ Anterior Cervical Plate System (November 18, 2022)
  • K211408 — CervAlign® Anterior Cervical Plate System (June 23, 2021)
  • K192396 — Streamline MIS Spinal Fixation System (November 26, 2019)
  • K140696 — STREAMLINE TL SPINAL FIXATION SYSTEM (April 10, 2014)
  • K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (March 27, 2014)
  • K133623 — C-PLUS (February 10, 2014)
  • K132050 — NB3D BONE VOID FILLER (February 7, 2014)
  • K133785 — TRITIUM STERNAL CABLE PLATE SYSTEM (January 27, 2014)
  • K131724 — PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (December 24, 2013)

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)
  • 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)