Home / 510(k) Clearances / K200518

510(k) K200518

Pitkar External Fixation System - Rail Mechanism by S.H.Pitkar Orthotools Pvt. , Ltd. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2020
Date Received
March 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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

  • K240233 — Pitkar Spinal Pedicle Screw System (September 9, 2024)
  • K200728 — Pitkar DeftFix System (October 6, 2020)
  • K192619 — Pitkar Locked Plating System (February 27, 2020)
  • K190486 — Pitkar External Fixation System (October 16, 2019)

Other clearances for product code KTT

  • K260900 — DYNEX® External Fixation Systems (April 17, 2026)
  • K260112 — QuikFix External Fixator: Knee-Spanning Pack (March 23, 2026)
  • K253291 — Excelsior System (January 20, 2026)
  • K253613 — Monkey Rings External Ring Fixation System (December 19, 2025)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K252555 — Medusa Orthopedics Boa External Fixation System (November 25, 2025)
  • K252625 — The Response Ortho Smart Fixator - Hexapod System (November 20, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250472 — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (August 8, 2025)