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510(k) K162801

CastleLoc Spinal Fixation System by L & K Biomed Co., Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2016
Date Received
October 5, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)
  • K151116 — CapLOX II/TowerLOX Pedicle Screw System (June 26, 2015)