FDA.report

510(k) K191433

Device
AGILON® XO Shoulder Replacement System
Applicant
Implantcast GmbH
510(k) number
K191433
Product code
HSD
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-12
Date received
2019-05-29
Regulation
888.3690
Classification name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Juliane Hoppner
Address
Lueneburger Schanze 26 Buxtehude DE 21614 21614

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code HSD

510(k)DeviceApplicantDecision date
K233260Univers Revers CA Head and AdapterArthrex, Inc.2024-02-12
K221232Univers Revers Humeral Cup ImplantArthrex, Inc.2022-05-19
K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC2020-05-15
K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.2018-04-18
K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.2016-11-21
K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH2016-11-01
K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc.2016-04-19
K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.2014-12-19
K131298EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEMExactech, Inc.2013-11-26
K130759HUMELOCK II CEMENTLESS SHOULDER SYSTEMFx Solutions2013-11-09
K130675ARTHREX UNIVERS II CA HEADSArthrex, Inc.2013-10-30
K130635SEVIIN SURFACE REPLACEMENT SHOULDERIngen Orthopedics, LLC2013-08-26
K121714SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSSmith & Nephew, Inc.2012-09-07
K112900SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSLima Corporate S.P.A.2012-06-01
K112983SPACER-STecres S.P.A.2011-12-12