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)

INHANCETM Hybrid Anatomic Glenoid Implant

K-Number: K212933 · 2022-06-08

ApplicantDepuy Ireland UC
Decision Date2022-06-08
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCETM Hybrid Anatomic Glenoid Implant is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2022-06-08 under approval number K212933. 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 INHANCETM Hybrid Anatomic Glenoid Implant?

INHANCETM Hybrid Anatomic Glenoid Implant is a medical device that received FDA 510(k) clearance on 2022-06-08. It is manufactured by Depuy Ireland UC. The 510(k) number is K212933.

When was INHANCETM Hybrid Anatomic Glenoid Implant approved by the FDA?

INHANCETM Hybrid Anatomic Glenoid Implant received FDA 510(k) clearance on 2022-06-08, under approval number K212933.

What company makes INHANCETM Hybrid Anatomic Glenoid Implant?

INHANCETM Hybrid Anatomic Glenoid Implant is manufactured by Depuy Ireland UC.

What is the FDA product code for INHANCETM Hybrid Anatomic Glenoid Implant?

The FDA product code for INHANCETM Hybrid Anatomic Glenoid Implant is MBF.

Related Clinical Trials

NCT04629391 Anatomic TSA vs RTSA for Glenohumeral Arthritis RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

Other Devices by Depuy Ireland UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K202098GLOBAL UNITE™ Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System

View all 48 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.

↑