Panels › Orthopedic › Product code MAI · Class 2
Fastener, Fixation, Biodegradable, Soft Tissue
Regulation 888.3030
5510(k)s in 12 months (221 all time)
9recalls in 12 months (97 all time)
96recalls that name a 510(k)
Top companies in MAI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2012 | K122869 | MILAGRO INTERFERENCE SCREWS Depuy Mitek, A Johnson & Johnson Company | MAI |
| Oct 3, 2012 | K122228 | LIGAFIX INTERFERENCE SCREW Sbm Sciences For Bio Materials, FR | MAI |
| Aug 22, 2012 | K121890 | GENESYS PRESSFT SUTURE ANCHOR Linvatec Corporation D/B/A Conmed Linvatec | MAI |
| Apr 24, 2012 | K120589 | MILAGRO INTERFERENCE SCREWS Depuy Mitek, A Johnson & Johnson Company | MAI |
| Mar 20, 2012 | K120540 | BIOBOLT Arthrex, Inc. | MAI |
| Feb 29, 2012 | K120078 | HEALIX ADVANCE BR ANCHOR Depuy Mitek Inc., Johnson and Johnson Company | MAI |
| Dec 20, 2011 | K113534 | HEALIX KNOTLESS ANCHOR Depuy Mitek, A Johnson & Johnson Company | MAI |
| Dec 15, 2011 | K112040 | ARTHREX BIOCOMPOSITE TRANSFIX Arthrex, Inc. | MAI |
| Oct 25, 2011 | K112249 | HEALIX KNOTLESS(TM) ANCHOR Depuy Mitek, A Johnson & Johnson Company | MAI |
| Jul 21, 2011 | K103831 | DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 Depuy Mitek, A Johnson & Johnson Company | MAI |
| Mar 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK Arthrex, Inc. | MAI |
| Feb 3, 2011 | K103309 | OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS Smith & Nephew Endoscopy, Inc. | MAI |
| Jan 27, 2011 | K101459 | OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 Smith & Nephew, Inc. | MAI |
| Jan 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS Arthrex, Inc. | MAI |
| Jan 5, 2011 | K102982 | ENDOBUTTON DIRECT Smith & Nephew Inc., Endoscopy Division | MAI |
| Oct 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS Arthrex, Inc. | MAI |
| Aug 26, 2010 | K101100 | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 Conmed Linvatec | MAI |
| Apr 30, 2010 | K100012 | GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A Depuy Mitek, A Johnson & Johnson Company | MAI |
| Apr 1, 2010 | K093844 | SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR Smith & Nephew, Inc. | MAI |
| Oct 19, 2009 | K092898 | CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES Conmed Linvatec | MAI |
| Aug 28, 2009 | K091844 | ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS Arthrex, Inc. | MAI |
| Aug 7, 2009 | K091041 | RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS Depuy Mitek, A Johnson & Johnson Company | MAI |
| Jun 22, 2009 | K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR Linvatec Corp. | MAI |
| Apr 10, 2009 | K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES Linvatec Corp. | MAI |
| Apr 3, 2009 | K090669 | RIGIDFIX BIOCRYL CROSS PIN KITS Depuy Mitek, A Johnson & Johnson Company | MAI |
| Mar 11, 2009 | K090124 | GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 Depuy Mitek, A Johnson & Johnson Company | MAI |
| Feb 12, 2009 | K083268 | TORNIER, INC., INSITE SUTURE ANCHORS Tornier, Inc. | MAI |
| Jan 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW Arthrex, Inc. | MAI |
| Dec 30, 2008 | K082999 | ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART Arthrex, Inc. | MAI |
| Jan 17, 2008 | K073412 | GRYPHON BR AND HEALIX BR ANCHORS Depuy Mitek, A Johnson & Johnson Company | MAI |
| Jan 17, 2008 | K071456 | ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT Arthrex, Inc. | MAI |
| Aug 3, 2007 | K071176 | MODIFICATION TO: ARTHREX INTERFERENCE SCREW Arthrex, Inc. | MAI |
| May 2, 2007 | K070925 | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR Depuy Mitek, A Johnson & Johnson Company | MAI |
| Apr 30, 2007 | K070178 | AESCULAP RESORBABLE PIN, MODEL FR735 Aesculap Implant System, Inc. | MAI |
| Apr 12, 2007 | K053492 | BIODUCT Bioduct, LLC | MAI |
| Dec 19, 2006 | K063497 | MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. | MAI |
| Nov 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW Arthrex, Inc. | MAI |
| Nov 9, 2006 | K062782 | INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 Inion OY, FI | MAI |
| Apr 11, 2006 | K060522 | SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. | MAI |
| Dec 16, 2005 | K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM Bonutti Research, Inc. | MAI |
| Aug 5, 2005 | K051983 | MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc. | MAI |
| Aug 4, 2005 | K051362 | INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 Inion OY, FI | MAI |
| Jun 29, 2005 | K051219 | PUSHLOCK Arthrex, Inc. | MAI |
| Jun 9, 2005 | K051250 | AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc. | MAI |
| Nov 19, 2004 | K042966 | DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H Linvatec Biomaterials, Ltd., FI | MAI |
| Oct 5, 2004 | K041698 | AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc. | MAI |
| Jul 29, 2004 | K041128 | SUTURE ARROW Linvatec Corp. | MAI |
| Jun 14, 2004 | K041307 | MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM Stryker Endoscopy | MAI |
| Jun 14, 2004 | K041305 | STRYKER BIOZIP SUTURE ANCHOR SYSTEM Stryker Endoscopy | MAI |
| Apr 30, 2004 | K040827 | PANALOK LOOP ANCHOR Depuy Mitek, A Johnson & Johnson Company | MAI |
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