FDA 510(k) Applications Submitted by DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040827 |
03/30/2004 |
PANALOK LOOP ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K041115 |
04/29/2004 |
GII QUICKANCHOR PLUS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K120589 |
02/28/2012 |
MILAGRO INTERFERENCE SCREWS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K111631 |
06/13/2011 |
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K112249 |
08/05/2011 |
HEALIX KNOTLESS(TM) ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K112417 |
08/23/2011 |
VARIOUS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K102443 |
08/26/2010 |
INTRAFIX TIBIAL SHEATH |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K113534 |
11/30/2011 |
HEALIX KNOTLESS ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K103831 |
12/30/2010 |
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K050771 |
03/25/2005 |
LUPINE LOOP |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K051989 |
07/22/2005 |
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K052630 |
09/26/2005 |
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K052631 |
09/26/2005 |
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130105 |
01/15/2013 |
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130539 |
03/01/2013 |
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K141259 |
05/15/2014 |
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K041069 |
04/26/2004 |
SPIRALOK ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K041075 |
04/26/2004 |
FASTIN RC ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K080352 |
02/11/2008 |
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K100532 |
02/25/2010 |
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K060553 |
03/01/2006 |
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130814 |
03/25/2013 |
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K070925 |
04/03/2007 |
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K071257 |
05/04/2007 |
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K131974 |
06/28/2013 |
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K062170 |
07/31/2006 |
BIOKNOTLESS AND LUPINE PLUS ANCHORS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K102298 |
08/13/2010 |
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K122869 |
09/19/2012 |
MILAGRO INTERFERENCE SCREWS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K103712 |
12/20/2010 |
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K100012 |
01/04/2010 |
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 |
| K060271 |
02/01/2006 |
SPIRALOK ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K060830 |
03/27/2006 |
MILAGRO INTERFERENCE SCREW |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K071481 |
05/29/2007 |
HEALIX ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K073412 |
12/04/2007 |
GRYPHON BR AND HEALIX BR ANCHORS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K041135 |
04/30/2004 |
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K041806 |
07/06/2004 |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K042233 |
08/18/2004 |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K073281 |
11/21/2007 |
CAIS STAPLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K063478 |
11/17/2006 |
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K120095 |
01/12/2012 |
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130169 |
01/24/2013 |
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K100638 |
03/05/2010 |
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K140896 |
04/08/2014 |
VAPR ARCTIC SUCTION ELECTRODE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K131191 |
04/26/2013 |
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K113545 |
12/01/2011 |
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130912 |
04/02/2013 |
OMNICUT RESECTION BLADE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K133794 |
12/13/2013 |
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K142574 |
09/12/2014 |
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K130917 |
04/03/2013 |
HEALIX ADVANCE KNOTLESS BR ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K122425 |
08/09/2012 |
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K123362 |
11/01/2012 |
MILAGRO ADVANCE INTERFERENCE SCREW |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K143660 |
12/23/2014 |
Milagro / Milagro Advance Interference Screw |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K132241 |
07/18/2013 |
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K090124 |
01/21/2009 |
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K090669 |
03/13/2009 |
RIGIDFIX BIOCRYL CROSS PIN KITS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K091041 |
04/13/2009 |
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 |
| K082643 |
09/11/2008 |
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| K092836 |
09/15/2009 |
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
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