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510(k) K131591

Device
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
Applicant
PEGA MEDICAL INC.
510(k) number
K131591
Product code
HWC  
Decision
Substantially Equivalent (SESE)
Decision date
2013-11-27
Date received
2013-05-31
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
ARIEL R DUJOVNE
Address
1111 Autoroute Chomedey Laval CA H7W 5J8 H7W 5J8

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
K261057ActivaScrew™ Cannulated COMBioretec, Ltd.2026-09-04
K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped2026-08-24
K262344Large Compression ScrewsTriMed, Inc.2026-08-12
K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.2026-08-05
K262075Lapidus Screw KitRelja Innovations, LLC2026-07-22
K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.2026-06-25
K253108VEOFIX Snap Off ScrewSteps Ortho2026-06-05
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

Legacy Summary#

summary

FDA Review#

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