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510(k) K130635

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

K130635 is an FDA 510(k) premarket notification submitted by Ingen Orthopedics, LLC for the device "SEVIIN SURFACE REPLACEMENT SHOULDER". The FDA issued a decision of Substantially Equivalent on August 26, 2013. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Ingen Orthopedics, LLC has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code HSD

  • K233260 — Univers Revers CA Head and Adapter (February 12, 2024)
  • K221232 — Univers Revers Humeral Cup Implant (May 19, 2022)
  • K191433 — AGILON® XO Shoulder Replacement System (November 12, 2020)
  • K193122 — Biocore9 Humeral Resurfacing System (May 15, 2020)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K161782 — Arthrex Univers Revers Shoulder Prosthesis System (November 21, 2016)
  • K161620 — Anatomical Shoulder Domelock Dome centric (November 1, 2016)
  • K151527 — Arthrex Univers Revers CA Heads and Adapters (April 19, 2016)
  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)

FDA data resources