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510(k) K982354

Device
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
Applicant
SPECIAL DEVICES, INC.
510(k) number
K982354
Product code
HTN  
Decision
Substantially Equivalent (SESE)
Decision date
1998-11-23
Date received
1998-07-06
Regulation
888.3030
Classification name
Washer, Bolt Nut
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH J SPRANZA
Address
12493 Old Rough And Ready Hwy. Grass Valley CA US 95945 95945

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

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FDA Review#

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