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510(k) K934366

Device
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
Applicant
MITEK SURGICAL PRODUCTS, INC.
510(k) number
K934366
Product code
HWC  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1994-10-07
Date received
1993-09-07
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT P ZOLETTI
Address
57 Providence Hwy. Norwood MA US 02062 02062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
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

Legacy Summary#

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FDA Review#

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