ClearanceBrief
Panels › Orthopedic › Product code MBI · Class 2

Fastener, Fixation, Nondegradable, Soft Tissue

Regulation 888.3040

32510(k)s in 12 months (606 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
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Top companies in MBI

Company510(k)sRecalls
Arthrex, Inc.521
ArthroCare Corporation311
Axya Medical, Inc.524
Smith & Nephew235
Riverpoint Medical231
Parcus Medical230
Innovasive Devices, Inc.220
Biomet, Inc.1010
CONMED Corporation161
Stryker106
Decided510(k)Device and applicantCode
Mar 18, 2013K122059ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
Smith & Nephew, Inc.
MBI
Mar 14, 2013K130351NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
Pivot Medical, Inc.
MBI
Mar 7, 2013K123350ECLIPSE SOFT TISSUE FASTENER
MedShape, Inc.
MBI
Mar 5, 2013K120740COLS® FIXATION SYSTEM
Fournitures Hospitalieres Industrie, FR
MBI
Feb 27, 2013K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
Arthrocare Corp.
MBI
Feb 21, 2013K123651CINCHLOCK KNOTLESS SUTURE ANCHOR
Pivot Medical
MBI
Feb 20, 2013K123425TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
Smith & Nephew, Inc.
MBI
Feb 14, 2013K123240SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
ArthroCare Corporation
MBI
Feb 5, 2013K122805PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
Parcus Medical, LLC
MBI
Jan 23, 2013K123579FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
Smith & Nephew, Inc.
MBI
Jan 9, 2013K122336Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
Eleven Blade Solutions, Inc.
MBI
Dec 21, 2012K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON
Arthrex, Inc.
MBI
Dec 19, 2012K122954CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
Foundry Newcoxi, Inc.
MBI
Dec 11, 2012K120356NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
Ncs Lab Srl, IT
MBI
Nov 9, 2012K121356MICRO/MINI N-PK(H) BONE ANCHOR
Anulex Technologies, Inc.
MBI
Nov 9, 2012K121354MICRO/MINI N-PK(F) BONE ANCHOR
Anulex Technologies, Inc.
MBI
Oct 31, 2012K122314QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
Cayenne Medical, Inc.
MBI
Oct 11, 2012K122463APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
Cayenne Medical, Inc.
MBI
Oct 2, 2012K1221236-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
Depuy Mitek, Inc., A Johnson and Johnson Company
MBI
Sep 21, 2012K120943SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
ArthroCare Corporation
MBI
Jul 26, 2012K120509STRYKER ALL SUTURE ANCHORS
Stryker
MBI
Jul 18, 2012K1208243.9MM REELX STT SUTURE ANCHOR SYSTEM
Stryker Corp.
MBI
Jun 22, 2012K121018BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
Smith & Nephew, Inc.
MBI
Jun 7, 2012K120841APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
Kfx Medical
MBI
Apr 20, 2012K120942PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
Parcus Medical, LLC
MBI
Mar 27, 2012K120096MULTIFIX P KNOTLESS FIXATION DEVICE
ArthroCare Corporation
MBI
Mar 6, 2012K113274FOOTPRINT ULTRA PK SUTURE ANCHOR
Smith & Nephew, Inc.
MBI
Mar 2, 2012K113297KNOTILUS ANCHOR SYSTEM
T.A.G. Medical Products Corporation, Ltd.
MBI
Feb 17, 2012K120155ARTHREX KNOTLESS SUTURETAK ANCHOR
Arthrex, Inc.
MBI
Jan 31, 2012K112526TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
Smith & Nephew, Inc.
MBI
Jan 20, 2012K113294SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
Smith & Nephew, Inc.
MBI
Jan 17, 2012K113730PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
Parcus Medical, LLC
MBI
Jan 17, 2012K112814CUFFINK
Cayenne Medical, Inc.
MBI
Jan 13, 2012K112417VARIOUS
Depuy Mitek, A Johnson & Johnson Company
MBI
Jan 9, 2012K112960LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
Cayenne Medical, Inc.
MBI
Dec 15, 2011K113299ROG SUTURE ANCHOR
Rog Sports Medicine, Inc.
MBI
Dec 15, 2011K112876CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
Cayenne Medical, Inc.
MBI
Dec 8, 2011K112991MODIFIED ROG SUTURE ANCHOR
Rog Sports Medicine, Inc.
MBI
Dec 1, 2011K112296LATERAL BUTTON
T.A.G. Medical Products Corporation, Ltd.
MBI
Nov 10, 2011K111716KNOTLESS SUTURE FIXATION SYSTEM
Core Essence Orthopaedics
MBI
Nov 2, 2011K112965NANO SUTURE ANCHOR
Linvatec Corporation D/B/A Conmed Linvatec
MBI
Sep 27, 2011K110800META-LOCK SUTURE ANCHOR SYSTEM
Tarsus Medical, Inc.
MBI
Aug 19, 2011K111661ARTHREX SCAPHOLUNATE ANCHOR
Arthrex, Inc.
MBI
Aug 19, 2011K110879BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
Biomet Sports Medicine
MBI
Aug 9, 2011K111044SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
ArthroCare Corporation
MBI
Aug 8, 2011K111779Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
Conmed Linvatec
MBI
Aug 8, 2011K111590ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
Rog Sports Medicine, Inc.
MBI
Jul 22, 2011K111631GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
Depuy Mitek, A Johnson & Johnson Company
MBI
Jul 20, 2011K111399SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
Arthrocare Corp.
MBI
Jul 12, 2011K111397TITAN TI SUTURE ANCHOR SYSTEM
Arthrocare Corp.
MBI

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