FDA 510(k) Applications Submitted by LISA GILMAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040197 |
01/29/2004 |
EAGLE ANTERIOR CERVIAL PLATE SYSTEM |
DEPUY ACROMED |
| K030383 |
02/05/2003 |
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS |
DEPUY ACROMED |
| K050675 |
03/16/2005 |
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE |
DEPUY SPINE, INC. |
| K080828 |
03/25/2008 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
| K010972 |
04/02/2001 |
ISOLA BAND CLAMP |
DEPUY ACROMED |
| K001105 |
04/05/2000 |
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS |
DEPUY ACROMED |
| K021148 |
04/10/2002 |
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD |
DEPUY ACROMED |
| K011182 |
04/18/2001 |
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS |
DEPUY ACROMED |
| K021335 |
04/26/2002 |
MONARCH SPINE SYSTEM |
DEPUY ACROMED |
| K031635 |
05/27/2003 |
DEPUY ACROMED VBR SYSTEM |
DEPUY ACROMED |
| DEN190029 |
06/03/2019 |
Acumen Assisted Fluid Management (AFM) Software Feature |
Edwards Lifesciences |
| K021879 |
06/07/2002 |
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) |
DEPUY ACROMED |
| K021880 |
06/07/2002 |
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) |
DEPUY ACROMED |
| K041722 |
06/24/2004 |
MODIFICATION TO VBR SPINAL SYSTEM |
DEPUY SPINE, INC. |
| K022285 |
07/15/2002 |
MODIFICATION TO ISOLA SPINAL SYSTEM |
DEPUY ACROMED |
| K092473 |
08/12/2009 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE,INC |
| K002607 |
08/22/2000 |
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS |
DEPUY ACROMED |
| K012916 |
08/30/2001 |
FRONTIER ANTERIOR SCOLIOSIS SYSTEM |
DEPUY ACROMED, INC. |
| K012971 |
09/05/2001 |
ISOLA SPINAL SYSTEMS |
DEPUY ACROMED |
| DEN160044 |
09/26/2016 |
Acumen Hypotension Prediction Index (HPI) Feature Software |
Edwards Lifesciences LLC |
| K052746 |
09/30/2005 |
CONCORDE VBR SPINAL SYSTEM |
DEPUY SPINE, INC. |
| K013294 |
10/02/2001 |
MONARCH SPINAL SYSTEMS |
DEPUY ACROMED |
| K013295 |
10/02/2001 |
TIMX SPINAL SYSTEMS |
DEPUY ACROMED |
| K013296 |
10/02/2001 |
MOSS MIAMI SPINAL SYSTEMS |
DEPUY ACROMED |
| K023438 |
10/15/2002 |
MODIFICATION TO MONARCH SPINE SYSTEM |
DEPUY ACROMED |
| K013441 |
10/17/2001 |
ISOLA POLYAXIAL WASHER |
DEPUY ACROMED |
| K203224 |
11/02/2020 |
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform |
Edwards Lifesciences, LLC |
| K023804 |
11/14/2002 |
MOSS MIAMI SPINAL SYSTEM PIN NUT |
DEPUY ACROMED |
| K183646 |
12/26/2018 |
Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure |
Edwards Lifeciences, LLC |
| K024348 |
12/30/2002 |
MONARCH SPINE SYSTEM |
DEPUY ACROMED |
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