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510(k) K161184

iNSitu Total Hip System by Theken Companies, LLC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2016
Date Received
April 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Theken Companies, LLC

  • K220336 — Mg-PSZ Ceramic Femoral Head (September 30, 2022)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K192071 — iNSitu Total Hip System (August 30, 2019)
  • K172501 — iNSitu Total Hip System (September 21, 2017)

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