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510(k) K213856

Identity Shoulder System by Zimmer, Inc. — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2022
Date Received
December 10, 2021
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

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  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
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Other clearances for product code MBF

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  • K233712 — PRIMA Humeral System; PRIMA TT Glenoid (January 11, 2024)
  • K231099 — SMR Hybrid Glenoid System (December 21, 2023)
  • K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (November 13, 2023)
  • K231516 — INHANCE™ Shoulder System, Sterile Single Use Instrumentation (July 21, 2023)
  • K223876 — SMR Shoulder System (February 3, 2023)
  • K222427 — PRIMA TT Glenoid (October 6, 2022)
  • K212933 — INHANCETM Hybrid Anatomic Glenoid Implant (June 8, 2022)