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510(k) K011583

Device
SPIKED WASHER
Applicant
SYNTHES (USA)
510(k) number
K011583
Product code
HTN  
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-30
Date received
2001-05-23
Regulation
888.3030
Classification name
Washer, Bolt Nut
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS M MAGUIRE
Address
1690 Russell Rd. Post Office Box 1766 Paoli PA US 19301 19301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HTN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253115LARS ACJMovmedix S.A.S.2026-06-10
K252081SportLinc Syndesmosis DeviceLincotek Medical2026-03-27
K253727Syndesmosis TightRope PROArthrex, Inc.2025-12-22
K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)2025-10-29
K251134RipCordTriMed, Inc.2025-07-11
K243624Acu-Sinch Knotless MiniAcumed, LLC2025-01-23
K242091Bolo Button SystemFusion Orthopedics2024-12-23
K243408TACTIX Vector Syndesmosis SystemVilex, LLC2024-11-27
K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.2024-11-01
K240035TACTIX Vector Syndesmosis SystemVilex, LLC2024-08-01
K240947TENSOR® Suture Button SystemGlobus Medical, Inc.2024-06-03
K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024-02-02
K232780CC-Clip® Implant SystemCc-Instruments, Inc.2023-12-18
K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2023-10-06
K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.2022-08-22

Legacy Summary#

summary

FDA Review#

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