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510(k) K223745

Novae® Dual Mobility System, Hype® Hip System by Serf — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
December 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Serf

  • K181744 — BI-MENTUM dual mobility system (December 11, 2018)
  • K142675 — CI../..X liner for NOVAE Dual Mobility Acetabular Cup (January 15, 2015)
  • K111572 — NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE (August 29, 2011)

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