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510(k) K161616

Device
DePuy Synthes 4.0 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4.0 Mm Cannulated Screws, DePuy Synthes 4.5 Mm Cannulated Screws, DePuy Synthes 6.5 Mm Cannulated Screws, DePuy Synthes 7.0 Mm And 7.3 Mm
Applicant
Synthes USA Products, LLC
510(k) number
K161616
Product code
HWC  
Decision
Substantially Equivalent (SESE)
Decision date
2017-02-16
Date received
2016-06-13
Regulation
888.3040
Classification name
Screw, 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
Nina Rudolph
Address
1301 Goshen Pkwy. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HWC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC2026-05-30
K261241TriMed Compression ScrewsTriMed, Inc.2026-05-14
K254215Arthrex Beaming SystemArthrex, Inc.2026-05-08
K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.2026-05-01
K260934TITAN Nail; APTUS K-Wire SystemMedartis AG2026-04-17
K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics2026-04-10
K253042Tyber Medical Trauma ScrewTyber Medical, LLC2026-04-03
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.2026-03-18
K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.2026-03-06
K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31
K251555Ultra™ Compression Screw SystemPace Surgical2025-11-06
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev42025-10-10
K250536MetaFore Small Screw SystemExtremity Medical, LLC2025-10-08
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29

Legacy Summary#

summary

FDA Review#

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