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510(k) K202716

Ignite Anatomic Shoulder System by Ignite Orthopedics, LLC — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2021
Date Received
September 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3670
Review Panel
OR
Submission Type

Other clearances by Ignite Orthopedics, LLC

  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)
  • K183618 — Revolution Radial Head (May 17, 2019)

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