BEUDAMED
    Product Code: HTN FDA class 2 21 CFR 888.3030

    Washer, Bolt Nut

    Orthopedic

    A bolt nut washer is a small metal orthopedic hardware component used in conjunction with bone screws and bolts to secure internal fixation implants during bone fracture repair or spinal stabilization. It is classified as an FDA Class 2 device under 21 CFR 888.3030, indicating moderate risk and requiring 510(k) premarket clearance. Product code HTN falls under the Orthopedic medical specialty. This device is an implant.

    View on FDA
    510(k)s
    89
    FEI Numbers
    262
    Registration Numbers
    262
    Unique Applicants
    52
    Years Active
    41

    Basic Information

    Product Code
    HTN
    Device Class
    FDA class 2
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 89 510(k) clearances via K numbers.

    K Number Device Name
    K251134 RipCord
    K243624 Acu-Sinch Knotless Mini
    K242091 Bolo Button System
    K243408 TACTIX Vector Syndesmosis System
    K242311 EXPERT - Flexible Joint Fixation System
    K240035 TACTIX Vector Syndesmosis System
    K240947 TENSOR® Suture Button System
    K233531 OIC FLEX-FIX™ System
    K232780 CC-Clip® Implant System
    K232755 Arthrex FiberTape and TigerTape Cerclage Sutures
    K221485 Arthrex FiberTape and TigerTape Cerclage Sutures
    K220947 Arthrex Knotless AC Repair Devices
    K220650 TriMed Ripcord Device
    K220260 Hercules Syndesmosis Implant System
    K212990 Acumed Ankle Syndesmosis Repair System
    K213644 Arthrex Knotless Mini TightRopes
    K211612 Medline UNITE REFLEX Dynamic Discs
    K200332 EXPERT - Joint Fixation System
    K201522 Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
    K200361 Akros Scruture Anchor LisFranc Repair Kit
    K190143 LARS AC Band Device
    K190582 MicroLink All-Suture Button Fixation System (Radiopaque)
    K190516 MicroLink All-Suture Button Fixation System (Radiolucent)
    K183094 CyclaPlex Correction System
    K183232 Double ENDOBUTTON Fixation Device
    K180243 Infinity-Lock Button System
    K171703 PUMA System
    K173550 Akros FibuLink™ Syndesmosis Repair Kit
    K172620 SyndesMetrics Syndesmosis Repair System
    K170249 GRAVITY™ Syndesmosis LP
    K162996 INVISIKNOT Ankle Syndesmosis Repair Kit
    K170440 KISSloc Suture System
    K162805 Akros Fibulink Syndesmosis Repair Kit
    K153211 M-Fix Acromioclavicular Device
    K150359 Tensyn Plug
    K143092 Tensyn Plug
    K141420 FASTFORWARD
    K141264 TENSYN BAND, TENSYN FRACTURE PLATES
    K141219 JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
    K133835 ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
    K140328 CMC MINI TIGHTROPE
    K133858 TENSYN BAND
    K133275 MINI TIGHTROPE
    K132733 ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
    K131850 TENSYN BAND
    K132510 BIOPRO - INFINITY PLATE ANCHOR SYSTEM
    K130986 FRAG-LOC SYSTEM
    K112437 ARTHREX FRACTURE SYSTEM
    K112111 ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
    K111032 CMC CABLE FIX
    K091207 SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
    K091799 CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
    K091763 MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
    K090107 MINI TIGHTROPE
    K082384 HAV-LOK BUNION CORRECTION SYSTEM
    K082095 ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
    K071978 MINI TIGHTROPE FT REPAIR KIT
    K061925 MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
    K052776 TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD
    K043145 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
    K043411 RESOFIX BIOABSORBABLE EXPANSION BOLT
    K043248 TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
    K040250 BONE-LOK HP WASHER
    K030619 ODI 7.0MM CANNULATED SCREW SYSTEM
    K023119 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
    K013806 SYNTHES METALLIC SPIKED WASHERS
    K011583 SPIKED WASHER
    K003496 CANNULATED SCREW SYSTEM
    K992617 HEX BUTTON
    K991135 SOFT TISSUE SUTURE WASHER
    K983906 DEPUY ORTHOTECH SPIKED WASHER
    K982354 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
    K983265 DEPUY ACE COMPOSITE LOCKING NUT
    K980944 SYNTHES SCHUHLI IMPLANT SYSTEM
    K965028 ACUMED SUTURE WASHER
    K963420 CANCELLOUS SCREW WASHER
    K954682 WASHER, BOLT, NUT, ORTHOPEDIC
    K954148 SUTURE WASHER
    K943782 BONE SCREW WASHER
    K924455 SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER
    K914472 SPIKED WASHER
    K911306 T-BOLT AND NUT
    K910186 WYMAN SUTURE WASHER
    K910229 SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
    K895107 ACE ORTHOPAEDIC WASHERS
    K881699 ACROMED WASHERS
    K874669 ACE BONE SCREW NUT
    K843368 KAPP SPINAL BUTTON
    K834411 TECHMEDICA-HEWSON SHOULDER CLEAT

    FEI Numbers

    This FDA classification entry is associated with 262 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 262 registration numbers. Click on an entry to view related FDA registrations.