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)

AEQUALIS PRESS-FIT SHOULDER PROSTHESIS

K-Number: K011942 · 2001-07-13

ApplicantTornier
Decision Date2001-07-13
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS PRESS-FIT SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2001-07-13 under 510(k) number K011942. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEQUALIS PRESS-FIT SHOULDER PROSTHESIS?

AEQUALIS PRESS-FIT SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 2001-07-13. The listed applicant is Tornier. The 510(k) number is K011942.

When did AEQUALIS PRESS-FIT SHOULDER PROSTHESIS receive FDA 510(k) clearance?

AEQUALIS PRESS-FIT SHOULDER PROSTHESIS received FDA 510(k) clearance on 2001-07-13, under 510(k) number K011942.

Who is the listed applicant for AEQUALIS PRESS-FIT SHOULDER PROSTHESIS?

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

What is the FDA product code for AEQUALIS PRESS-FIT SHOULDER PROSTHESIS?

The FDA product code for AEQUALIS PRESS-FIT SHOULDER PROSTHESIS is HSD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tornier 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.

K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISK111970KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTK111902AEQUALIS SHOULDER SYSTEMK094013HLS KNEETEC SYSTEMK100142AEQUALIS REVERSED SHOULDER PROSTHESISK091870TORNIER, PITON FIXATION IMPLANT SYSTEM

View all 44 devices →

Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.

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.

↑