FDA.reportPublic FDA data

510(k) K984498

Device
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
Applicant
SYNTHES (USA)
510(k) number
K984498
Product code
KTT  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-18
Date received
1998-12-17
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANGELA J SILVESTRI
Address
P.O. Box 1766 1690 Russell Rd. Paoli PA US 19301 19301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KTT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC2026-06-11
K260900DYNEX® External Fixation SystemsVilex, LLC2026-04-17
K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.2026-03-23
K253291Excelsior SystemBlue Ocean Global2026-01-20
K253202Hoffmann LRF SystemStryker GmbH2025-12-19
K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.2025-12-19
K252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC2025-11-25
K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC2025-11-20
K252106External Fixation Mini Rail SystemParagon 28, Inc.2025-09-30
K251862External Fixation Bone DistractorParagon 28, Inc.2025-08-11
K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.2025-08-08
K251128Extremity Medical External Fixation SystemExtremity Medical, LLC2025-05-07
K243798Orthex External Fixation SystemOrthoPediatrics Corp.2025-03-07
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025-02-21
K242861TrueLok ElevateOrthofix Srl2024-12-03

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases