Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
33510(k)s in 12 months (607 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 53 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2009 | K083150 | G-FORCE TENODESIS SCREW Wrightmedicaltechnologyinc | MBI |
| Jan 12, 2009 | K083240 | OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES Arthrocare Corp. | MBI |
| Dec 19, 2008 | K082729 | RIMCLOSE BONE ANCHOR Anulex Technologies, Inc. | MBI |
| Dec 16, 2008 | K083070 | TOGGLELOC SYSTEM Biomet Sports Medicine | MBI |
| Oct 17, 2008 | K081348 | TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD TriMed, Inc. | MBI |
| Aug 26, 2008 | K081511 | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S Smith & Nephew, Inc. | MBI |
| Jul 28, 2008 | K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) Arthrocare Corp. | MBI |
| Jul 3, 2008 | K081598 | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE Kfx Medical | MBI |
| Jun 13, 2008 | K080447 | SURGICRAFT SCREW FIXATION SYSTEM Surgicraft , Ltd. | MBI |
| Apr 23, 2008 | K080335 | TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM Tornier, Inc. | MBI |
| Feb 29, 2008 | K080229 | 5.5 MM SUTURE LOCK BONE SCREW ANCHOR Kfx Medical | MBI |
| Jan 7, 2008 | K073481 | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES Conmed Linvatec | MBI |
| Dec 7, 2007 | K073226 | CINCH KNOTLESS FIXATION IMPLANT SYSTEM C2m Medical, Inc. | MBI |
| Oct 26, 2007 | K072063 | KFX TISSUE FIXATION SYSTEM AND ACCESSORIES Kfx Medical | MBI |
| Oct 11, 2007 | K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR Axya Medical, Inc. | MBI |
| Sep 17, 2007 | K071704 | SLEEVE AND BUTTON SOFT TISSUE DEVICES Biomet Sports Medicine, Inc. | MBI |
| Aug 21, 2007 | K070780 | CONMED LINVATEC XO BUTTON Conmed Linvatec | MBI |
| Aug 17, 2007 | K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division | MBI |
| Aug 10, 2007 | K071520 | RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X Core Essence Orthopaedics, LLC | MBI |
| Aug 2, 2007 | K071374 | OPUS TWINLOCK KNOTLESS FIXATION DEVICE Arthrocare Corp. | MBI |
| Jul 20, 2007 | K070882 | STRYKER PEEK TWINLOOP TAC Stryker Endoscopy | MBI |
| Jul 2, 2007 | K071569 | ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER Biomet, Inc. | MBI |
| May 16, 2007 | K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division | MBI |
| May 16, 2007 | K070758 | STRYKER PEEK ZIP SUTURE ANCHOR Stryker Endoscopy | MBI |
| Apr 16, 2007 | K070227 | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE Arthrocare Corp. | MBI |
| Apr 12, 2007 | K070167 | ENDOBUTTON DIRECT Smith & Nephew Inc., Endoscopy Division | MBI |
| Feb 13, 2007 | K062739 | CINCH BONE ANCHOR SYSTEM Sapphire Medical, Inc. | MBI |
| Jan 25, 2007 | K063577 | FEMORAL INTRAFIX SCREW AND SHEATH Johnson & Johnson Company | MBI |
| Dec 19, 2006 | K063499 | MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. | MBI |
| Jul 19, 2006 | K061294 | KFX KNOTLESS FIXATION SYSTEM Kfx Medical | MBI |
| Jul 14, 2006 | K061349 | OPUS LABRALOCK P KNOTLESS FIXATION DEVICE Arthrocare Corp. | MBI |
| Jun 8, 2006 | K061154 | KINSA SUTURE ANCHOR Smith & Nephew, Inc. | MBI |
| Feb 3, 2006 | K053461 | EZLOC FEMORAL FIXATION DEVICE Arthrotek, Inc. | MBI |
| Dec 20, 2005 | K052810 | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. | MBI |
| Dec 5, 2005 | K052572 | ANSPACH KNOTLESS ANCHOR The Anspach Effort, Inc. | MBI |
| Oct 7, 2005 | K052491 | AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR Axya Medical, Inc. | MBI |
| Jun 29, 2005 | K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER Arthrotek, Inc. | MBI |
| Mar 2, 2005 | K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER Linvatec Corp. | MBI |
| Nov 12, 2004 | K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE Opus Medical, Inc. | MBI |
| Oct 29, 2004 | K042460 | TI - SCREW ANCHOR SP Arthrotek, Inc. | MBI |
| Jul 22, 2004 | K041713 | SUPER REVO HERCULINE SUTURE ANCHOR Linvatec Corp. | MBI |
| Jun 25, 2004 | K041440 | OPUS MAGNUM ANCHOR WITH INSERTER Opus Medical, Inc. | MBI |
| Jun 14, 2004 | K041310 | STRYKER WEDGE SUTURE ANCHOR SYSTEM Stryker Endoscopy | MBI |
| Jun 7, 2004 | K041261 | FEMORAL HOOK Arthrotek, Inc. | MBI |
| Feb 13, 2004 | K033838 | TITANIUM TOGGLE BUTTON(S) Biomet Manufacturing, Inc. | MBI |
| May 5, 2003 | K023963 | ADHOC CLAW Future Medical Systems, Inc. | MBI |
| Nov 25, 2002 | K022853 | ENDOTACK KARL STORZ Endoscopy-America, Inc. | MBI |
| Nov 22, 2002 | K022827 | ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR Linvatec Corp. | MBI |
| Oct 4, 2002 | K022207 | AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM Axya Medical, Inc. | MBI |
| Jul 22, 2002 | K020172 | OPUS MAGNUM ANCHOR & INSTRUMENT SET Opus Medical, Inc. | MBI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.