FDA 510(k) Applications Submitted by Lisa Simpson
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010081 |
01/10/2001 |
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS |
EXACTECH, INC. |
| K120122 |
01/17/2012 |
SENSE MSK S 8CH 1.5T |
INVIVO CORPORATION |
| K060180 |
01/23/2006 |
BIOSET XC |
REGENERATION TECHNOLOGIES, INC. |
| K060253 |
02/01/2006 |
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. |
REGENERATION TECHNOLOGIES, INC. |
| K010434 |
02/13/2001 |
OPTETRAK B-SERIES TOTAL KNEE SYSTEM |
EXACTECH, INC. |
| K050398 |
02/16/2005 |
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS |
EXACTECH, INC. |
| K140946 |
04/14/2014 |
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE |
NovaBone Products, LLC |
| K001335 |
04/27/2000 |
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED |
EXACTECH, INC. |
| K141207 |
05/09/2014 |
NOVABONE BIOACTIVE STRIP |
NovaBone Products, LLC |
| K051858 |
07/08/2005 |
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM |
EXACTECH, INC. |
| K002141 |
07/17/2000 |
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT |
EXACTECH, INC. |
| K072327 |
08/20/2007 |
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON |
REGENERATION TECHNOLOGIES, INC. |
| K122646 |
08/30/2012 |
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T |
INVIVO CORPORATION |
| K142712 |
09/22/2014 |
Dental Collagen Wound Dressing (Nova Tape and NovaPlug) |
NovaBone Products, LLC |
| K133030 |
09/26/2013 |
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) |
INVIVO CORPORATION |
| K042842 |
10/14/2004 |
NOVATION 12/14 PRESS-FIT FEMORAL STEM |
EXACTECH, INC. |
| K023646 |
10/30/2002 |
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM |
EXACTECH, INC. |
| K123492 |
11/13/2012 |
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) |
PHILIPS MEDICAL SYSTEMS |
| K063584 |
12/01/2006 |
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 |
REGENERATION TECHNOLOGIES, INC. |
| K043403 |
12/10/2004 |
CEMEX SYSTEM GENTA FAST BONE CEMENT |
EXACTECH, INC. |
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