FDA 510(k) Applications Submitted by RICHARD O WOOD, ESQ.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K080302 |
02/05/2008 |
CAYMAN BUTTRESS PLATE SYSTEM |
K2M, INC. |
K092211 |
07/22/2009 |
CHESAPEAKE SPINAL SYSTEM |
K2M, INC. |
K082698 |
09/15/2008 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
K960238 |
01/16/1996 |
CPR SUTURE REMOVAL KIT |
CUSTOM PACK RELIABILITY |
K960236 |
01/16/1996 |
CPR LAP SPONGES |
CUSTOM PACK RELIABILITY |
K960223 |
01/16/1996 |
CPR YANKAUER |
CUSTOM PACK RELIABILITY |
K960239 |
01/16/1996 |
CPR D & C TRAY |
CUSTOM PACK RELIABILITY |
K960218 |
01/16/1996 |
CONNECTING TUBING |
CUSTOM PACK RELIABILITY |
K960217 |
01/16/1996 |
CPR URINE BAG |
CUSTOM PACK RELIABILITY |
K960216 |
01/16/1996 |
CPR SUCTION CATHETER KIT |
CUSTOM PACK RELIABILITY |
K960215 |
01/16/1996 |
CPR URETHRAL CATHETER TRAY |
CUSTOM PACK RELIABILITY |
K960214 |
01/16/1996 |
CPR FOLEY CAHTETER KIT |
CUSTOM PACK RELIABILITY |
K960213 |
01/16/1996 |
CPR TOTAL HIP PACK |
CUSTOM PACK RELIABILITY |
K960212 |
01/16/1996 |
CPR IRRIGATION TRAY |
CUSTOM PACK RELIABILITY |
K960211 |
01/16/1996 |
CPR TOTAL KNEE PACK |
CUSTOM PACK RELIABILITY |
K960210 |
01/16/1996 |
CPR ORTHO HAND PACK |
CUSTOM PACK RELIABILITY |
K960208 |
01/16/1996 |
CPR BASIC SET-UP TRAY |
CUSTOM PACK RELIABILITY |
K960209 |
01/16/1996 |
CPR HEART PACK |
CUSTOM PACK RELIABILITY |
K960207 |
01/16/1996 |
CPR LACERATION TRAY |
CUSTOM PACK RELIABILITY |
K960206 |
01/16/1996 |
CPR DRESSING CHANGE TRAY |
CUSTOM PACK RELIABILITY |
K960205 |
01/16/1996 |
CPR TRACHEOTOMY CARE TRAY |
CUSTOM PACK RELIABILITY |
K960241 |
01/16/1996 |
CPR GENERAL SURGERY TRAY |
CUSTOM PACK RELIABILITY |
K960242 |
01/16/1996 |
CPR EYE TRAY |
CUSTOM PACK RELIABILITY |
K960243 |
01/16/1996 |
CPR C-SECTION DELIVERY PACK |
CUSTOM PACK RELIABILITY |
K070139 |
01/16/2007 |
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 |
SURVIVAIR, INC. |
K960520 |
02/06/1996 |
LACERATION TRAY |
MEDCO INSTRUMENTS, INC. |
K050486 |
02/25/2005 |
PROTECT TOOTH DESENSITIZER |
SUNSTAR BUTLER |
K070782 |
03/21/2007 |
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F |
SURVIVAIR RESPIRATORS, LLC |
K040849 |
04/01/2004 |
MENTAMOVE |
COLE & ASSOCIATES |
K962370 |
06/19/1996 |
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE |
CHALLENGE PRODUCTS, INC. |
K071911 |
07/11/2007 |
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR |
INNOVISION A/S |
K051907 |
07/14/2005 |
INNOCOR |
INNOVISION A/S |
K023005 |
09/09/2002 |
AQUILLA MODULAR WHEELCHAIR |
HAYWOOD VOCATIONAL OPPORTUNITIES |
K042630 |
09/27/2004 |
REVLIGHT SKIN CARE SYSTEM |
SKINCARE TECHNOLOGY INC. |
K962989 |
08/01/1996 |
AMOILS EPITHELIAL SCRUBBER |
S. PERCY AMOILS |
K080024 |
01/04/2008 |
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 |
K2M, INC. |
K100061 |
01/11/2010 |
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX |
K2M, INC. |
K070229 |
01/24/2007 |
RANGE SPINAL SYSTEM |
K2M, INC. |
K080611 |
03/04/2008 |
MESA SPINAL SYSTEM |
K2M, INC. |
K080792 |
03/20/2008 |
K2M COCR ROD |
K2M, INC. |
K081107 |
04/18/2008 |
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS |
K2M, INC. |
K091253 |
04/29/2009 |
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS |
K2M, INC. |
K081381 |
05/16/2008 |
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS |
K2M, INC. |
K081380 |
05/16/2008 |
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS |
K2M, INC. |
K092474 |
08/12/2009 |
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS |
K2M, INC. |
K092640 |
08/27/2009 |
CASPIAN SPINAL SYSTEM |
K2M, INC. |
K052398 |
08/31/2005 |
MESA SPINAL SYSTEM |
K2M, LLC |
K052404 |
09/01/2005 |
DENALI DEFORMITY SYSTEM |
K2M, LLC |
K082769 |
09/22/2008 |
MESA AND RANGE SPINAL SYSTEMS |
K2M, INC. |
K042635 |
09/27/2004 |
DENALI SPINE SYSTEM |
K2M, LLC |
K072914 |
10/12/2007 |
NATURAL BRIDGE LP TRANSVERSE CONNECTORS |
K2M, INC. |
K014164 |
12/19/2001 |
GREAT TOE IMPLANT SYSTEM |
HARMOS ORTHOPAEDICS, INC. |
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