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510(k) K183129

Medtronic Total Hip Arthroplasty System by Medtronic Advanced Energy — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
November 13, 2018
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

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  • K152703 — PlasmaBlade TnA Tonsil and Adenoid Dissection Device (July 8, 2016)
  • K150297 — PlasmaBlade UPPP and Suction Coagulator (May 21, 2015)
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  • K132974 — AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDUR (December 3, 2013)
  • K123201 — AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER (January 10, 2013)
  • K120909 — EC 2.7 ENDOSCOPIC CUTTER (November 2, 2012)

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