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510(k) K240233

Pitkar Spinal Pedicle Screw System by S.H.Pitkar Orthotools Pvt. , Ltd. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2024
Date Received
January 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by S.H.Pitkar Orthotools Pvt. , Ltd.

  • K200728 — Pitkar DeftFix System (October 6, 2020)
  • K200518 — Pitkar External Fixation System - Rail Mechanism (July 29, 2020)
  • K192619 — Pitkar Locked Plating System (February 27, 2020)
  • K190486 — Pitkar External Fixation System (October 16, 2019)

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  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
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