FDA 510(k) Applications Submitted by SUZANA OTANO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100238 |
01/27/2010 |
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM |
DEPUY ORTHOPAEDICS, INC. |
| K090374 |
02/17/2009 |
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S |
DEPUY ORTHOPAEDICS, INC. |
| K090492 |
02/25/2009 |
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS |
DEPUY ORTHOPAEDICS, INC. |
| K140622 |
03/11/2014 |
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE |
BIOMET, INC. |
| K090877 |
03/31/2009 |
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS |
DEPUY ORTHOPAEDICS, INC. |
| K150867 |
04/01/2015 |
Affixus Tibial Nailing System |
BIOMET, INC. |
| K111077 |
04/18/2011 |
ORTHOSORB RESORBABLE PINS |
DEPUY ORTHOPAEDICS, INC. |
| K081155 |
04/23/2008 |
SMARTSET MV BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
| K081163 |
04/24/2008 |
SMARTSET GMV GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
| K091294 |
05/04/2009 |
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, |
DEPUY ORTHOPAEDICS, INC. |
| K101240 |
05/04/2010 |
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 |
DEPUY ORTHOPAEDICS, INC. |
| K091453 |
05/18/2009 |
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 |
DEPUY ORTHOPAEDICS, INC. |
| K101421 |
05/20/2010 |
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 |
DEPUY ORTHOPAEDICS, INC. |
| K111444 |
05/24/2011 |
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION |
DEPUY ORTHOPAEDICS, INC. |
| K081546 |
06/02/2008 |
SMALL BONE LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K131670 |
06/07/2013 |
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) |
BIOMET, INC. |
| K111663 |
06/14/2011 |
TRAUMA INTERNAL FIXATION SYSTEMS |
DEPUY ORTHOPAEDICS, INC. |
| K131867 |
06/24/2013 |
2.5MM INLINE FUSION PLATE |
BIOMET, INC. |
| K072083 |
07/30/2007 |
SMALL FRAGMENT LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K112218 |
08/02/2011 |
ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS |
DEPUY ORTHOPAEDICS, INC. |
| K082300 |
08/12/2008 |
ANATOMIC LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K112345 |
08/15/2011 |
DISTAL VOLAR RADIUS PLATING SYSTEMS |
MEDOS INTERNATIONAL SARL |
| K072423 |
08/29/2007 |
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. |
DEPUY ORTHOPAEDICS, INC. |
| K132704 |
08/29/2013 |
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW |
BIOMET |
| K072832 |
10/03/2007 |
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K162897 |
10/17/2016 |
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser |
BECKMAN COULTER |
| K093474 |
11/06/2009 |
DEPUY FRACTURE AND FUSION PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K083364 |
11/13/2008 |
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 |
DEPUY ORTHOPAEDICS, INC. |
| K103408 |
11/19/2010 |
POSTERIOR LATERAL PLATES |
DEPUY ORTHOPAEDICS, INC. |
| K083789 |
12/19/2008 |
ACE FISCHER EXTERNAL FIXATION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K133939 |
12/23/2013 |
MODIFIED DISTAL RADIUS PLATING SYSTEM |
BIOMET |
| K083843 |
12/24/2008 |
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K052509 |
09/13/2005 |
M-BOLUS EMBOLIC MICROSPHERES |
SCION CARDIO-VASCULAR, INC. |
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