FDA 510(k) Applications Submitted by DAVID HENLEY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050226 |
02/01/2005 |
ASIAN INTRAMEDULLARY HIP SCREW NAILS |
SMITH & NEPHEW, INC. |
| K030344 |
02/03/2003 |
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS |
SMITH & NEPHEW, INC. |
| K130479 |
02/25/2013 |
ILIZAROV DRILL TIP WIRES |
SMITH & NEPHEW, INC. |
| K120667 |
03/05/2012 |
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT |
SMITH & NEPHEW, INC. |
| K110670 |
03/09/2011 |
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES |
SMITH & NEPHEW, INC. |
| K050849 |
04/04/2005 |
HA COATED LAG SCREW |
SMITH & NEPHEW, INC. |
| K991162 |
04/07/1999 |
BIOLOX ALUMINA CERAMIC FEMORAL HEAD |
SMITH & NEPHEW, INC. |
| K061019 |
04/13/2006 |
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS |
SMITH & NEPHEW, INC. |
| K031181 |
04/15/2003 |
EXTERNAL FIXATION SYSTEMS |
SMITH & NEPHEW, INC. |
| K991485 |
04/28/1999 |
SYNERGY POROUS SIZE 8 HIP STEM |
SMITH & NEPHEW, INC. |
| K061352 |
05/15/2006 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY |
SMITH & NEPHEW, INC. |
| K071563 |
06/07/2007 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
| K051557 |
06/13/2005 |
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS |
SMITH & NEPHEW, INC. |
| K051735 |
06/28/2005 |
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY |
SMITH & NEPHEW, INC. |
| K092015 |
07/06/2009 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
| K012378 |
07/26/2001 |
3D HUMERAL HEADS |
SMITH & NEPHEW, INC. |
| K062216 |
08/01/2006 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
| K072212 |
08/09/2007 |
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE |
SMITH & NEPHEW, INC. |
| K022688 |
08/13/2002 |
VERSABOND AB BONE CEMENT |
SMITH & NEPHEW, INC. |
| K012778 |
08/20/2001 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS |
SMITH & NEPHEW, INC. |
| K012787 |
08/20/2001 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE |
SMITH & NEPHEW, INC. |
| K012788 |
08/20/2001 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II |
SMITH & NEPHEW, INC. |
| K042312 |
08/26/2004 |
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE |
SMITH & NEPHEW, INC. |
| K022902 |
09/03/2002 |
SMITH & NEPHEW HIP SYSTEM |
SMITH & NEPHEW, INC. |
| K002747 |
09/05/2000 |
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
| K092748 |
09/08/2009 |
SURESHOT TAN NAILS AND ACCESSORIES |
SMITH & NEPHEW, INC. |
| K132886 |
09/16/2013 |
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM |
SMITH & NEPHEW, INC. |
| K023134 |
09/20/2002 |
JET-X TIN COATED HALF PINS |
SMITH & NEPHEW, INC. |
| K002996 |
09/25/2000 |
SYNERGY HA COATED POROUS FEMORAL STEMS |
SMITH & NEPHEW, INC. |
| K072818 |
10/02/2007 |
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS |
SMITH & NEPHEW, INC. |
| K023302 |
10/03/2002 |
ECHELON POROUS PLUS HA HIP STEMS |
SMITH & NEPHEW, INC. |
| K112941 |
10/04/2011 |
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS |
SMITH & NEPHEW, INC. |
| K083032 |
10/10/2008 |
PERI-LOC BONE PLATING AND SCREW SYSTEM |
SMITH & NEPHEW, INC. |
| K033289 |
10/14/2003 |
MODIFICATION TO JET-X HA COATED HALF PINS |
SMITH & NEPHEW, INC. |
| K023680 |
11/01/2002 |
BIOBUCK CEMENT RESTRICTOR |
SMITH & NEPHEW, INC. |
| K013658 |
11/06/2001 |
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
| K033509 |
11/06/2003 |
MODIFICATION TO VERSABOND BONE CEMENT |
SMITH & NEPHEW, INC. |
| K003566 |
11/20/2000 |
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS |
SMITH & NEPHEW, INC. |
| K033669 |
11/21/2003 |
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) |
SMITH & NEPHEW, INC. |
| K023921 |
11/25/2002 |
JET-X HA COATED HALF PINS |
SMITH & NEPHEW, INC. |
| K994143 |
12/08/1999 |
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] |
SMITH & NEPHEW, INC. |
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