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
Jul 2, 2015K143745Arthrex Corkscrew and SwiveLock Suture Anchors
Arthrex, Inc.
MBI
Jun 29, 2015K151201Stryker ICONIX with Needles
Stryker
MBI
Jun 19, 2015K151230Arthrex FiberTak Anchors
Arthrex, Inc.
MBI
May 15, 2015K150424JuggerStitch Meniscal Repair Device
Biomet Manufacturing Corp
MBI
Mar 25, 2015K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.
Cayenne Medical, Inc.
MBI
Feb 23, 2015K150166Extremity Medical Suture Anchor
Extremity Medical, LLC
MBI
Jan 23, 2015K143392Quattro Bolt Tenodesis Screw
Cayenne Medical, Inc.
MBI
Dec 15, 2014K142643Stabilynx PEEK Suture Anchor
D3 Dc, LLC /Stabilynx, Inc.
MBI
Oct 24, 2014K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Pe
Depuy Mitek, A Johnson & Johnson Company
MBI
Oct 16, 2014K142653G-Lok and G-Lok XL Extender
T.A.G. Medical Products Corporation, Ltd., IL
MBI
Sep 10, 2014K142230Apollo Suture Anchor System and Titan Screws
Valeris Medical
MBI
Aug 13, 2014K140476ARTHREX FIBERTAK SUTURE ANCHOR
Arthrex, Inc.
MBI
Jul 30, 2014K141011G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
Wrightmedicaltechnologyinc
MBI
Jul 24, 2014K141711PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
Pontis Orthopaeeics, LLC
MBI
Jul 21, 2014K140879BIOSURE HEALICOIL PK INTERFERENCE SCREW
Smith & Nephew, Inc.
MBI
Jul 7, 2014K140324RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
Depuy Mitek, A Johnson and Johnson Company
MBI
Jun 26, 2014K133579MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
Pontis Orthopaedics, LLC
MBI
May 20, 2014K140925ACUMED SUTURE ANCHOR SYSTEM
Acumed, LLC
MBI
May 14, 2014K140604MULTIFIX S KNOTLESS FIXATION SYSTEM
ArthroCare Corporation
MBI
Apr 17, 2014K132724ICONN ANSWER SUTURE ANCHOR
Iconn Orthopedics, LLC
MBI
Apr 7, 2014K133235THREADED PEEK K-WIRE
Mtp Solutions, LLC
MBI
Apr 4, 2014K133777TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
Tornier, Inc.
MBI
Apr 1, 2014K133606N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
ArthroCare Corporation
MBI
Mar 10, 2014K133469ACUMED SUTURE ANCHOR SYSTEM
Acumed, LLC
MBI
Mar 6, 2014K133036APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
Amendia, Inc.
MBI
Feb 28, 2014K133671ICONIX ALL SUTURE ANCHORS
Stryker Corp.
MBI
Feb 4, 2014K133757GFS II STANDARD, GFS II LARGE, GFS MIMI
Parcus Medical, LLC
MBI
Jan 30, 2014K133229TITANIUM SUTURE ANCHOR
Mtp Solutions, LLC
MBI
Jan 16, 2014K133727Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU
ArthroCare Corporation
MBI
Jan 3, 2014K133224Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES
Conmed Corporation
MBI
Dec 30, 2013K132867SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
Cayenne Medical, Inc.
MBI
Dec 9, 2013K132783EXOSHAPE DUO SOFT TISSUE FASTENER
MedShape, Inc.
MBI
Dec 5, 2013K130467POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
MedShape, Inc.
MBI
Oct 18, 2013K122437NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
Biomet Sports Medicine
MBI
Oct 16, 2013K132461A.I.M. SUTURE ANCHOR
Anchor Innovation Medical, Inc.
MBI
Oct 7, 2013K131769CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
Pivot Medical, Inc.
MBI
Sep 19, 2013K132632TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
Tornier, Inc.
MBI
Sep 19, 2013K132513Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
ArthroCare Corporation
MBI
Sep 17, 2013K1325905.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
ArthroCare Corporation
MBI
Aug 29, 2013K131635ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
Rotation Medical, Inc.
MBI
Aug 16, 2013K131325QUATTRO GL SUTURE ANCHOR
Cayenne Medical, Inc.
MBI
Aug 1, 2013K130814RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
Depuy Mitek, A Johnson & Johnson Company
MBI
Aug 1, 2013K130033TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
Biomet Manufacturing Corp
MBI
Jul 29, 2013K131182MULTIFIX S KNOTLESS FIXATION DEVICE
Arthocare Corporation
MBI
Jul 2, 2013K131035Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
Linvatec Corporation D/B/A Conmed Linvatec
MBI
Jun 27, 2013K131683HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
Depuy Mitek, Inc., A Johnson and Johnson Company
MBI
Jun 20, 2013K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
OrthoPediatrics Corp.
MBI
May 21, 2013K130539HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
Depuy Mitek, A Johnson & Johnson Company
MBI
May 3, 2013K130458KNOTLESS FIBERTAK SUTURE ANCHOR
Arthrex, Inc.
MBI
Mar 18, 2013K123485JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
Biomet Sports Medicine
MBI

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