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510(k) K945294

Device
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
Applicant
HOWMEDICA CORP.
510(k) number
K945294
Product code
JDQ  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-03-07
Date received
1994-10-31
Regulation
888.3010
Classification name
Cerclage, Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT E SMITH
Address
359 Veterans Blvd. Rutherford NJ US 07070 07070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.2026-07-16
K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.2025-08-14
K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.2025-02-20
K232733Mbrace CableMedacta International S.A.2024-05-03
K233949ACCORD Cable SystemSmith & Nephew, Inc.2024-03-13
K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.2024-01-30
K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.2023-08-24
K231333STRETTO™ Cable SystemGlobus Medical, Inc.2023-08-04
K220765HS Fiber CerclageRiverpoint Medical, LLC2023-07-26
K221795STERN FIX Sternal Stabilization SystemNeos Surgery S.L2022-10-19
K211613Stern Fix Sternal Stabilization SystemNeos Surgery S.L2022-01-19
K201497EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-10-28
K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020-10-16
K193479Sternal Cable SystemA & E Medical Corporation2020-03-23
K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-03-12

Legacy Summary#

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FDA Review#

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