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510(k) K030302

Device
HBS HEADLESS BONE SCREW
Applicant
SCHOENING & ASSOC., INC.
510(k) number
K030302
Product code
HWC  
Decision
Substantially Equivalent (SESE)
Decision date
2003-08-08
Date received
2003-01-29
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Kevin Walls
Address
13 Red Fox Ln. Littleton CO US 80127 80127

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
00841742144986HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144849HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144856HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144863HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144870HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144887HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144894HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144900HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144917HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144924HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144931HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144948HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144955HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144962HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144979HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145136HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742144993HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145006HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145013HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145020HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145037HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145044HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145051HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145068HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145075HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145082HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145099HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145105HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145112HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07
00841742145129HNM TOTAL RECONHNM TOTAL RECON LLC2016-10-07

Other 510(k) Records For Product Code HWC  

510(k)DeviceApplicantDecision date
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
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27

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FDA Review

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