FDA.reportPublic FDA data

510(k) K231262

Device
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
Applicant
Stryker GmbH
510(k) number
K231262
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-18
Date received
2023-05-01
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Danese Joiner-Fox
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026-05-09
K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026-04-30
K260411PC Fix SystemChest Wall Innovations, Inc.2026-04-24
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24
K260054I.T.S. PRS Phoenix III.T.S. GmbH2026-04-24
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.2026-04-10
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.2026-04-01
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026-03-25
K260274Airlock® Ankle Plating SystemNovastep SAS2026-03-25
K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG2026-03-24
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.2026-03-23
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.2026-03-19
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-03-17
K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.2026-03-17
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026-03-16