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)

REVERSE SHOULDER PROSTHESIS MONOBLOCK

K-Number: K130048 · 2013-10-29

ApplicantEncore Medical L.P.
Decision Date2013-10-29
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVERSE SHOULDER PROSTHESIS MONOBLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2013-10-29 under 510(k) number K130048. 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 REVERSE SHOULDER PROSTHESIS MONOBLOCK?

REVERSE SHOULDER PROSTHESIS MONOBLOCK is a medical device that received FDA 510(k) clearance on 2013-10-29. The listed applicant is Encore Medical L.P.. The 510(k) number is K130048.

When did REVERSE SHOULDER PROSTHESIS MONOBLOCK receive FDA 510(k) clearance?

REVERSE SHOULDER PROSTHESIS MONOBLOCK received FDA 510(k) clearance on 2013-10-29, under 510(k) number K130048.

Who is the listed applicant for REVERSE SHOULDER PROSTHESIS MONOBLOCK?

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

What is the FDA product code for REVERSE SHOULDER PROSTHESIS MONOBLOCK?

The FDA product code for REVERSE SHOULDER PROSTHESIS MONOBLOCK 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 Encore Medical L.P. 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.

K252567AltiVate Reverse® ADLC GlenosphereK252974EMPOWR KneeK251833EMPOWR Acetabular® Liner ExtensionK252141AltiVate Reverse® GlenoidK251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

View all 75 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.

↑