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510(k) K130635

SEVIIN SURFACE REPLACEMENT SHOULDER by Ingen Orthopedics, LLC — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2013
Date Received
March 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type

Other clearances by Ingen Orthopedics, LLC

  • K131277 — SEVIIN FRACTURE SHOULDER (August 28, 2013)
  • K120374 — SEVIIN REVERSE SHOULDER (July 9, 2012)

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