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510(k) K211408

CervAlign® Anterior Cervical Plate System by Pioneer Surgical Technology, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2021
Date Received
May 6, 2021
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.

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  • 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)
  • K131100 — STREAMLINE TL SPINAL SYSTEM (June 27, 2013)

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