Product Code: MAI


Products Classified as MAI

4611Fastener, Fixation, Biodegradable, Soft TissueSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

Total Product Life Cycle (TPLC) Devices

4611Fastener, Fixation, Biodegradable, Soft TissueSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

FDA Consensus Standards

Fastener, Fixation, Biodegradable, Soft Tissue [37410]21 CFR §888.3030 🔎
Fastener, Fixation, Biodegradable, Soft Tissue [37411]21 CFR §888.3030 🔎
Fastener, Fixation, Biodegradable, Soft Tissue [35572]21 CFR §888.3030 🔎

Pre-market Notifications for MAI

K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula SystemB-ONE ORTHO, Corp
K210239CITRESPLINE And CITRELOCK ACL ImplantsAcuitive Technologies, Inc.
K210122Sterile Bioabsorbable Bone Screw (Bioabsorbable ACL Screw)Osteonic Co., Ltd.
K203523Fixone Hybrid Knotless AnchorAJU Pharm Co., Ltd.
K203493MectaLock ExtensionMedacta International SA
K203334The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc.
K201786Arthrex Mini Hip PushLockArthrex Inc.
K201749Arthrex SwiveLock AnchorArthrex Inc.
K201414Rotium Bioresorbable WickNanofiber Solutions, LLC
K200725Citregen Tendon Interference Screw And CitrelockAcuitive Technologies
K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.
K193503Arthrex SwiveLock Suture AnchorArthrex Inc.
K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex Inc.
K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLC
K192532Arthrex SwiveLock AnchorArthrex Inc.

Global Unique Device Identification Database

00885556714973Fastener, fixation, biodegradable, soft tissue
00885556714966Fastener, fixation, biodegradable, soft tissue
00885556714959Fastener, fixation, biodegradable, soft tissue
00885556714942Fastener, fixation, biodegradable, soft tissue
00885556714935Fastener, fixation, biodegradable, soft tissue
00885556714928Fastener, fixation, biodegradable, soft tissue
00885556714911Fastener, fixation, biodegradable, soft tissue
00885556710319Fastener, fixation, biodegradable, soft tissue
00885556710302Fastener, fixation, biodegradable, soft tissue
00885556710296Fastener, fixation, biodegradable, soft tissue
00885556571057Fastener, fixation, biodegradable, soft tissue
00885556570395Fastener, fixation, biodegradable, soft tissue
00885556533291Fastener, fixation, biodegradable, soft tissue
00885556533277Fastener, fixation, biodegradable, soft tissue
00885556529423FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Maude Adverse Events

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BKSMITH & NEPHEW, INC.2020-03-31
COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MMS.B.M. SAS2020-03-31
SCREW BIOSURE REGENESORB 6MM X 20MMSMITH & NEPHEW, INC.2020-03-29
MILAGRO INSCR SMALL SIZE 6X30DEPUY MITEK LLC US2020-03-27
OSTEORAPTOR 2.3 W. UB COBRAID BLUESMITH & NEPHEW, INC.2020-03-26
4.5 HEALIX ADVANCE BR W/OCORDDEPUY MITEK LLC US2020-03-26
MILAGRO INSCR SMALL SIZE 5X30DEPUY MITEK LLC US2020-03-26
IMPL SYS,BIO-COMP ACHILLES SPEEDBRGARTHREX, INC.2020-03-26
6.5 HEALIXADV BR3SUTANC PCORDDEPUY MITEK LLC US2020-03-25
4.5 HEALIXADV BR3SUTANC PCORDDEPUY MITEK LLC US2020-03-25
4.75 HEALIX ADVANCE KNTLSS BRDEPUY MITEK LLC US2020-03-25
5.5 HEALIX BR ANCHOR W/OC&NDDEPUY MITEK LLC US2020-03-25
4.75 HEALIX ADVANCE KNTLSS BRDEPUY MITEK LLC US2020-03-24
BIOKNOTLESS RAPIDE W/PANDEPUY MITEK LLC US2020-03-24
4.5 HEALIX ADVANCE BR3SUT W/OCDEPUY MITEK LLC US2020-03-24
ARTHREX?ARTHREX, INC.2020-03-24
COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MMS.B.M. SAS2020-03-23
OMNISPAN MENISCAL REPAIR 12DEGDEPUY MITEK LLC US2020-03-20
OMNISPAN MENISCAL REPAIR 12DEGDEPUY MITEK LLC US2020-03-20
MINILOK QA+ #2-0 OC RB-1DEPUY MITEK LLC US2020-03-20
MINILOK QA+ #2-0 OC RB-1DEPUY MITEK LLC US2020-03-20
MINILOK QA+ #2-0 OC RB-1DEPUY MITEK LLC US2020-03-20
OSTEORAPTORSMITH & NEPHEW, INC.2020-03-19
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-19
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-19
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-19
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-19
4.9MM HEALX ADV SP BIOC ANCHORMEDOS INTERNATIONAL SàRL2020-03-19
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-19
4.75 HEALIX ADVANCE KNTLSS BRDEPUY MITEK LLC US2020-03-18
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BLSMITH & NEPHEW, INC.2020-03-17
VERSALOK PEEK WITH ORTHOCORDDEPUY MITEK LLC US2020-03-17
COMPOSITE SCREW LIGAFIX 60 DIAM. 9 - L:25 MMS.B.M. SAS2020-03-17
HEALICOIL RG SA 4.75MM W/2 UB-BL CBRD BLSMITH & NEPHEW, INC.2020-03-12
4.75 HEALIX ADVANCE KNTLS BRMEDOS INTERNATIONAL SàRL2020-03-10
4.75 HEALIX ADVANCE KNTLS BRMEDOS INTERNATIONAL SàRL2020-03-10
4.75 HEALIX ADVANCE KNTLS BRMEDOS INTERNATIONAL SàRL2020-03-10
MILAGRO ADVANCE SCREW 9X23MMDEPUY MITEK LLC US2020-03-10
GRYPHON PEEK W/PROKNOTDEPUY MITEK LLC US2020-03-10
MICRORAPTOR KNOTLESS SA PEEKSMITH & NEPHEW, INC.2020-03-10
TWINFIX ULTRA PLLA/HA 5.5 W/3 UBSMITH & NEPHEW, INC.2020-03-09
SUTR ANCH,BIO-COMP S-TAK SM JNTARTHREX, INC.2020-03-09
SCREW BIOSURE REGENESORB 9MM X 30MMSMITH & NEPHEW, INC.2020-03-08
5.5 HEALIX PEEK ANCH.W/OCORDDEPUY MITEK LLC US2020-03-06
5.5 HEALIX ADVANCE KNTLSS BRDEPUY MITEK LLC US2020-03-06
BIOKNOTLESS RAPIDE W/PANDEPUY MITEK LLC US2020-03-06
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-06
LUPINE BR DS W/ORTHCRDDEPUY MITEK LLC US2020-03-06
5.5 HEALIX ADVANCE KNTLSS BRDEPUY MITEK LLC US2020-03-06
UNKNOWN JUGGERSTICHZIMMER BIOMET, INC.2020-03-06

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