FDA 510(k) Applications Submitted by LOUISE M FOCHT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120029 |
01/04/2012 |
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
| K100905 |
04/01/2010 |
HYDROFIX SURGICAL SHEET |
MIMEDX GROUP, INC |
| K233044 |
09/25/2023 |
Tandem Mobi insulin pump with interoperable technology |
Tandem Diabetes Care Inc. |
| K023416 |
10/11/2002 |
MODIFICATION TO VKS KNEE SYSTEM |
PLUS ORTHOPEDICS |
| K023604 |
10/28/2002 |
MODIFICATION TO RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K113752 |
12/21/2011 |
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
| K974911 |
12/31/1997 |
EXTERNAL FIXATOR |
AVANTA ORTHOPAEDICS, INC. |
| K060071 |
01/09/2006 |
NEXA COMPRESSION SCREW |
NEXA ORTHOPEDICS, INC. |
| K060386 |
02/14/2006 |
NEXA CARPO METACARPAL IMPLANT |
NEXA ORTHOPEDICS, INC. |
| K990596 |
02/24/1999 |
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM |
AVANTA ORTHOPAEDICS, INC. |
| K040497 |
02/26/2004 |
DISTAL RADIO-ULNAR JOINT IMPLANT |
APTIS MEDICAL, LLC. |
| K070688 |
03/12/2007 |
NEXFIX COMPRESSION STAPLE |
NEXA ORTHOPEDICS, INC. |
| K010786 |
03/15/2001 |
ULNAR HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K010847 |
03/21/2001 |
K'FIX |
AVANTA ORTHOPAEDICS, INC. |
| K981715 |
05/15/1998 |
DISTAL RADIUS FRACTURE FIXATION PLATE |
AVANTA ORTHOPAEDICS, INC. |
| K981716 |
05/15/1998 |
EXTERNAL FIXATION |
AVANTA ORTHOPAEDICS, INC. |
| K051406 |
05/31/2005 |
OSTEOCURE RESORBABLE BEAD KIT |
NEXA ORTHOPEDICS, INC. |
| K021859 |
06/06/2002 |
WRIST IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K011819 |
06/11/2001 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K051740 |
06/28/2005 |
TAPERED COMPRESSION PIN |
NEXA ORTHOPEDICS, INC. |
| K982268 |
06/29/1998 |
ULNAR HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K982288 |
06/30/1998 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K022204 |
07/05/2002 |
VKS KNEE SYSTEM |
PLUS ORTHOPEDICS |
| K002644 |
08/24/2000 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K023086 |
09/17/2002 |
CLASSIC GREAT TOE IMPLANT |
NEXA ORTHOPEDICS, INC. |
| K032902 |
09/17/2003 |
SUBTALAR ARTHRORISIS IMPLANT |
NEXA ORTHOPEDICS, INC. |
| K003033 |
09/28/2000 |
SCAPHIX, STAPLE, FIXATION, BONE |
AVANTA ORTHOPAEDICS, INC. |
| K033046 |
09/29/2003 |
SUBTALAR PEG IMPLANT |
NEXA ORTHOPEDICS, INC. |
| K023531 |
10/21/2002 |
LESSER METATARSAL PHALANGEAL JOINT IMPLANT |
NEXA ORTHOPEDICS, INC. |
| K023562 |
10/23/2002 |
MODIFICATION TO CLASSIC GREAT TOE IMPLANT |
NEXA ORTHOPEDICS, INC. |
| K964359 |
11/01/1996 |
AVANTA ORTHOPAEDICS TENDON SPACER |
AVANTA ORTHOPAEDICS, INC. |
| K964381 |
11/04/1996 |
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
| K013629 |
11/05/2001 |
FINGER JOINT PROSTHESIS |
AVANTA ORTHOPAEDICS, INC. |
| K053394 |
12/06/2005 |
NEXA BONE SCREW SYSTEM |
NEXA ORTHOPEDICS, INC. |
| K053408 |
12/07/2005 |
NEXA BONE PLATE AND SCREW SYSTEM |
NEXA ORTHOPEDICS, INC. |
| K965204 |
12/26/1996 |
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
|
|
