Product Code: MBI


Products Classified as MBI

4617Fastener, Fixation, Nondegradable, Soft TissueSmooth Or Threaded Metallic Bone Fixation Fastener.

Total Product Life Cycle (TPLC) Devices

4617Fastener, Fixation, Nondegradable, Soft TissueSmooth Or Threaded Metallic Bone Fixation Fastener.

FDA Consensus Standards

Fastener, Fixation, Nondegradable, Soft Tissue [34059]21 CFR §888.3040 🔎
Fastener, Fixation, Nondegradable, Soft Tissue [34070]21 CFR §888.3040 🔎
Fastener, Fixation, Nondegradable, Soft Tissue [37410]21 CFR §888.3040 🔎
Fastener, Fixation, Nondegradable, Soft Tissue [37411]21 CFR §888.3040 🔎
Fastener, Fixation, Nondegradable, Soft Tissue [35572]21 CFR §888.3040 🔎

Pre-market Notifications for MBI

K222763Responsive Arthroscopy Mustang And Mustang Knotless Suture AnchorsResponsive Arthroscopy LLC
K222169FairFix Adjustable Button SystemMedacta International SA
K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex Inc.
K222091Grappler Suture Anchor SystemParagon 28, Inc.
K221731FiberStitch Implant, Curved With Two Polyester Implants And 2-0 FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0 FiberWireT.A.G. Medical Products Corporation, Ltd
K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.
K221364Mitek TIGHT-N AnchorMedos International SARL
K221135X-Twist PEEK Suture AnchorParcus Medical LLC
K220901S-Core Implant SystemSubchondral Solutions, Inc.
K220797FootHold SystemCrossRoads Extremity Systems, LLC
K220757Argo Knotless SP AnchorCONMED Corporation
K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited
K213018Auxilock GFS Mini, GFS II Large, And GFS UltimateAuxein Medical Private Limited
K212739ActiFlipParcus Medical LLC.
K212197WasherCap Fixation SystemAbanza Tecnomed SL.

Global Unique Device Identification Database

00812444028577Fastener, Fixation, Nondegradable, Soft Tissue
00812444028560Fastener, Fixation, Nondegradable, Soft Tissue
00812444028553Fastener, Fixation, Nondegradable, Soft Tissue
00812444028546Fastener, Fixation, Nondegradable, Soft Tissue
00812444028539Fastener, Fixation, Nondegradable, Soft Tissue
00812444028522Fastener, Fixation, Nondegradable, Soft Tissue
00812444028515Fastener, Fixation, Nondegradable, Soft Tissue
00812444028508Fastener, Fixation, Nondegradable, Soft Tissue
00812444028430Fastener, Fixation, Nondegradable, Soft Tissue
00812444028416Fastener, Fixation, Nondegradable, Soft Tissue
00812444028409Fastener, Fixation, Nondegradable, Soft Tissue
00812444028232Fastener, Fixation, Nondegradable, Soft Tissue
00812444028225Fastener, Fixation, Nondegradable, Soft Tissue
00812444028218Fastener, Fixation, Nondegradable, Soft Tissue
00812444028201Fastener, Fixation, Nondegradable, Soft Tissue

Maude Adverse Events

SUTUREFIX ULTRA AHR S 2 UB STR CB BLUSMITH & NEPHEW, INC.2020-03-31
TRUESPAN 24 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-31
JGRKNT LONG 1 #2 BLUE MBZIMMER BIOMET, INC.2020-03-31
2.8MM Q-FIX ALL SUTURE ANCHORARTHROCARE CORP.2020-03-30
TRUESPAN 24 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-30
FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5SMITH & NEPHEW, INC.2020-03-30
TRUESPAN 0 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-30
TRUESPAN 24 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-30
JUGGERSTITCH STRAIGHT IMPLANTZIMMER BIOMET, INC.2020-03-30
FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5SMITH & NEPHEW, INC.2020-03-29
HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LTSMITH & NEPHEW, INC.2020-03-29
TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BLSMITH & NEPHEW, INC.2020-03-28
2.8MM Q-FIX ALL SUTURE ANCHORARTHROCARE CORP.2020-03-28
MICRORAPTOR KNOTLESS SA PEEKSMITH & NEPHEW, INC.2020-03-28
ULTRABUTTON ADJUSTABLE FIXATION DEVICEARTHROCARE CORP.2020-03-27
JUGGERSTITCH STRAIGHT IMPLANTZIMMER BIOMET, INC.2020-03-27
FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5SMITH & NEPHEW, INC.2020-03-26
MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHORARTHROCARE CORP.2020-03-26
MILAGRO ADV PEEK SCREW 9X30MMMEDOS INTERNATIONAL SàRL2020-03-26
JGRKNT 1.0MM MINI 2-0 NDLSZIMMER BIOMET, INC.2020-03-26
JGRKNT 1.0MM MINI 2-0 NDLSZIMMER BIOMET, INC.2020-03-26
RGDLOOP ADJUSTABLE LONGMEDOS INTERNATIONAL SàRL2020-03-25
JGRKNT LONG CURVED DISP KITZIMMER BIOMET, INC.2020-03-25
TRUESPAN 12 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-24
TRUESPAN 24 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-24
TRUESPAN 12 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-24
MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHORARTHROCARE CORP.2020-03-24
JUGGERKNOT SOFT ANCHORSBIOMET, INC.2020-03-24
ARTHREX?ARTHREX, INC.2020-03-24
2.8MM Q-FIX ALL SUTURE ANCHORARTHROCARE CORP.2020-03-23
BIORAPTOR KNOTLESS SUTURE ANCHORSMITH & NEPHEW, INC.2020-03-23
TRUESPAN 12 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-19
3.5MM POPLOK SUTURE ANCHORCONMED CORPORATION2020-03-19
4.5MM POPLOK SUTURE ANCHORCONMED CORPORATION2020-03-19
REELX STT 4.5MM KNOTLESS ANCHORSTRYKER ENDOSCOPY-SAN JOSE2020-03-18
2.8MM Q-FIX ALL SUTURE ANCHORARTHROCARE CORP.2020-03-18
TRUESPAN 12 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-18
TRUESPAN 12 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-18
SPEEDLOCK HIP KNOTLESS FIXATION DEVICEARTHROCARE CORP.2020-03-17
HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BLSMITH & NEPHEW, INC.2020-03-17
TENOTAC SOFT TISSUE FIXATION SYSTEMPARAGON 28, INC.2020-03-17
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORTBOSTON SCIENTIFIC CORPORATION2020-03-17
TENOTAC SOFT TISSUE FIXATION SYSTEMPARAGON 28, INC.2020-03-17
TRUESPAN 0 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-16
TRUESPAN 0 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-16
JGRKNT 1.0MM MINI 2-0 NDLSZIMMER BIOMET, INC.2020-03-16
JUGGERKNOT 1.4MM SHRT W/NDLSZIMMER BIOMET, INC.2020-03-16
JGRKNT 1.0MM MINI 3-0 NDLSZIMMER BIOMET, INC.2020-03-16
3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURECONMED CORPORATION2020-03-16
TRUESPAN 24 DEGREE PEEKMEDOS INTERNATIONAL SàRL2020-03-16
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