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510(k) K192071

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2019
Date Received
August 2, 2019
Clearance Type
Special
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)
  • K172501 — iNSitu Total Hip System (September 21, 2017)
  • K161184 — iNSitu Total Hip System (October 14, 2016)

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