FDA.report

510(k) K231188

Device
ALIGN Radial Head System
Applicant
Skeletal Dynamics, Inc.
510(k) number
K231188
Product code
KWI
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-28
Date received
2023-04-26
Regulation
888.3170
Classification name
Prosthesis, Elbow, Hemi-, Radial, Polymer
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
Alexandra Rodriguez Rojas
Address
7300 N Kendall Dr. Miami FL US 33156 33156

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code KWI

510(k)DeviceApplicantDecision date
K233592BioPoly Radial Head ImplantBioPoly, LLC2024-03-13
K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes2022-03-18
K212872Avenger Radial Head SystemIn2bones USA, LLC2021-12-17
K192754Avenger Radial Head SystemIn2bones USA, LLC2020-01-07
K183618Revolution Radial HeadIgnite Orthopedics, Inc.2019-05-17
K172688Align Radial Head SystemSkeletal Dynamics, LLC2017-12-22
K132735AXIA RADIAL HEAD SYSTEMImds (Innovative MEdical Device Systems) - Leis ME2014-01-07
K131845ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOCAcumed, LLC2013-09-30
K112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMSynthes USA, LLC2012-06-19
K092721ALIGN RADIAL HEAD SYSTEMSkeletal Dynamics, LLC2010-08-03
K062898SBI LATERAL RHEAD IMPLANTSmall Bone Innovations, Inc.2006-11-13
K060731EVOLVE MODULAR RADIAL HEADWrightmedicaltechnologyinc2006-04-19
K051385EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc.2005-08-05
K041858ACUMED ANATOMIC RADIAL HEAD SYSTEMAcumed, LLC2004-10-05
K040611MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc.2004-06-04