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510(k) K150741

TSolution One w/ACG surgical System by THINK Surgical, Inc. — Product Code OJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2015
Date Received
March 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Computer Controlled Surgical System
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

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Other clearances for product code OJP

  • K140585 — CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM (August 18, 2014)
  • K140038 — DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM (May 27, 2014)
  • K072629 — DIGIMATCH ROBODOC SURGICAL SYSTEM (August 6, 2008)