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510(k) K183060

CervAlign™ Anterior Cervical Plate System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2019
Date Received
November 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

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  • K193468 — Tritium Sternal Cable Plate System (March 12, 2020)
  • K192800 — Streamline TL Spinal Fixation System (January 14, 2020)
  • K172139 — Streamline OCT Occipito-Cervico-Thoracic System (August 18, 2017)
  • K161498 — Streamline OCT Occipito-Cervico-Thoracic System (August 22, 2016)
  • K153735 — Release Laminoplasty Fixation System (January 21, 2016)
  • K150581 — Tritium Sternal Cable Plate System (June 4, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)

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