Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2022-06-08 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K212933.

When did INHANCETM Hybrid Anatomic Glenoid Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for INHANCETM Hybrid Anatomic Glenoid Implant?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Depuy Ireland UC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemK260480VELYS™ Robotic-Assisted SolutionK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementK253624INHANCE™ Reverse Shoulder SystemK253551VELYS™ Hip NavigationK253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

View all 50 devices →

Related Devices (Code: MBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima 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.

↑