Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Identity Shoulder System

K-Number: K240876 · 2024-06-12

ApplicantZimmer, Inc.
Decision Date2024-06-12
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Identity Shoulder System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2024-06-12 under approval number K240876. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Identity Shoulder System?

Identity Shoulder System is a medical device that received FDA 510(k) clearance on 2024-06-12. It is manufactured by Zimmer, Inc.. The 510(k) number is K240876.

When was Identity Shoulder System approved by the FDA?

Identity Shoulder System received FDA 510(k) clearance on 2024-06-12, under approval number K240876.

What company makes Identity Shoulder System?

Identity Shoulder System is manufactured by Zimmer, Inc..

What is the FDA product code for Identity Shoulder System?

The FDA product code for Identity Shoulder System is MBF.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Zimmer, Inc.

K161830Zimmer M/L Taper Hip Prosthesis K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid K172114Zimmer Natural Nail System K181761Zimmer Biomet Select Ceramic Heads

View all 58 devices →

Related Devices (Code: MBF)

K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie K173824Humeral Short Stem SystemShoulder Innovations, Inc. K191963SMR Finned Short StemsLima Corporate S.P.A. K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑