Product Code: HTN


Products Classified as HTN

4478Washer, Bolt NutSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

Total Product Life Cycle (TPLC) Devices

4478Washer, Bolt NutSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

FDA Consensus Standards

Washer, Bolt Nut [37410]21 CFR §888.3030 🔎
Washer, Bolt Nut [37411]21 CFR §888.3030 🔎

Pre-market Notifications for HTN

K220650TriMed Ripcord DeviceTriMed, Inc.
K220260Hercules Syndesmosis Implant SystemIn2Bones USA, LLC
K213644Arthrex Knotless Mini TightRopesArthrex Inc.
K212990Acumed Ankle Syndesmosis Repair SystemAcumed LLC
K211612Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc.
K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex Inc.
K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical
K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria E Comercio Ltda
K190582MicroLink All-Suture Button Fixation System (Radiopaque)CONMED Corporation
K190516MicroLink All-Suture Button Fixation System (Radiolucent)CONMED Corporation
K190143LARS AC Band DeviceCorin USA
K183232Double ENDOBUTTON Fixation DeviceSmith And Nephew, Inc.
K183094CyclaPlex Correction SystemCycla Orthopedics Ltd
K180243Infinity-Lock Button SystemXiros Ltd
K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical

Global Unique Device Identification Database

00811954012984Washer, Bolt Nut
00816988012634Washer, Bolt Nut
00816988011736Washer, Bolt Nut
00815612020564Washer, Bolt Nut
00815612020557Washer, Bolt Nut
00815612020236Washer, Bolt Nut
00885556643570WASHER, BOLT NUT
00885556643563WASHER, BOLT NUT
00885556642368WASHER, BOLT NUT
00885556642115WASHER, BOLT NUT
00885556642085WASHER, BOLT NUT
00885556641903WASHER, BOLT NUT
00885556641866WASHER, BOLT NUT
00885556641859WASHER, BOLT NUT
00885556641842WASHER, BOLT NUT

Maude Adverse Events

K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2020-03-26
IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MMARTHREX, INC.2020-03-26
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-24
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-24
UNK - WASHERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-20
UNK - WASHERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-20
MICROLINK, ALL SUTURE BUTTON FIXATION SYSTEMCONMED CORPORATION2020-03-17
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-13
UNKNOWN KNEE FEMORAL ADAPTOR BOLTDEPUY ORTHOPAEDICS INC US2020-03-02
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2020-02-26
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2020-02-26
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2020-02-25
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2020-02-25
UNKNOWN KNEE FEMORAL ADAPTOR BOLTDEPUY ORTHOPAEDICS INC US2020-02-21
OMNIEXTREMITY MEDICAL, LLC.2020-02-12
MINI TIGHTROPE REPAIRARTHREX, INC.2020-02-04
KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SSARTHREX, INC.2020-01-27
BUTTON, DOG BONEARTHREX, INC.2020-01-27
BUTTON, DOG BONEARTHREX, INC.2020-01-27
JGRLOC B2B RD SS SLD DRL KITZIMMER BIOMET, INC.2020-01-02
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-25
UNK - WASHERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-22
UNK - WASHERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-22
UNK - WASHERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-22
UNK - WASHERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-22
ACU-SINCH? KITACUMEDLLC2019-11-18
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-13
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-13
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-01
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2019-10-30
KNOTLESS T-ROPE SYN-DESMOSIS REPR TIARTHREX, INC.2019-10-23
MTO ENDOBUTTON TWINBRIDGE FIX DEVICESMITH & NEPHEW, INC.2019-10-07
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-04
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-04
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2019-10-01
SMITH & NEPHEW ENDOBUTTONSMITH & NEPHEW INC.2019-09-19
K-LESS T-ROPE W/DRV, SYN REPR, SSARTHREX, INC.2019-09-18
BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-09-06
BOLT, NUT, WASHEROBERDORF SYNTHES PRODUKTIONS GMBH2019-09-05
WASHER 13.0MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-08-29
K-LESS T-ROPE W/DRV, SYN REPR, TIARTHREX, INC.2019-08-21
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-08-20
UNK - WASHERSOBERDORF SYNTHES PRODUKTIONS GMBH2019-08-20
JGRLOC B2B RD SS SLD DRL KITZIMMER BIOMET, INC.2019-08-16
ACU-SINCH? KITACUMED LLC2019-08-01
IMPL SYS,CMC MINI T-ROPE,1.1 MMARTHREX, INC.2019-06-27
ACUTE AC REPAIR KITARTHREX, INC.2019-05-23
PUMA SYSTEMPANTHER ORTHOPEDICS, INC.2019-05-01
JGRLOC B2B RD TI SLD DRL KITZIMMER BIOMET, INC.2019-04-23
JGRLOC B2B RD TI SLD DRL KITZIMMER BIOMET, INC.2019-04-23

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