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 REVERSED FRACTURE SHOULDER PROTHESIS

K-Number: K082120 · 2008-10-24

ApplicantTornier
Decision Date2008-10-24
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K082120. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS?

AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Tornier. The 510(k) number is K082120.

When did AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS receive FDA 510(k) clearance?

AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS received FDA 510(k) clearance on 2008-10-24, under 510(k) number K082120.

Who is the listed applicant for AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS?

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 REVERSED FRACTURE SHOULDER PROTHESIS?

The FDA product code for AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS is KWS.

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: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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.

↑