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510(k) K133374

STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM by Pioneer Surgical Technology, Inc. (Rti Surgical, I — Product Code KWP

K133374 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. (Rti Surgical, I for the device "STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM". The FDA issued a decision of Substantially Equivalent on March 19, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Pioneer Surgical Technology, Inc. (Rti Surgical, I has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2014
Date Received
November 1, 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

Other clearances by Pioneer Surgical Technology, Inc. (Rti Surgical, I

  • K141600 — NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT (October 17, 2014)

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