FDA 510(k) Applications Submitted by AMY L WALTERS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000248 |
01/27/2000 |
CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K000332 |
02/03/2000 |
NOGA CARDIAC NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K130387 |
02/15/2013 |
ORTHOALIGN PLUS SYSTEM |
ORTHALIGN, INC |
| K961555 |
04/22/1996 |
ACUFEX TAG BIOABSORBABLE ANCHORS |
ACUFEX MICROSURGICAL, INC. |
| K091411 |
05/13/2009 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
| K013083 |
09/14/2001 |
CARTO XP EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
| K954935 |
10/27/1995 |
S-ROM FEMORAL HIP STEM - SIZE 14 X 8 |
JOINT MEDICAL PRODUCTS CORP. |
| K093998 |
12/28/2009 |
KNEEALIGN SYSTEM WITH REFERENCE SENSOR |
ORTHALIGN, INC |
| K103829 |
12/30/2010 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
| K990414 |
02/10/1999 |
SMITH & NEPHEW HANDPORT SYSTEM |
SMITH & NEPHEW, INC. |
| K970949 |
03/14/1997 |
SMITH & NEPHEW MIS INSTRUMENTS |
SMITH & NEPHEW ENDOSCOPY, INC. |
| K971939 |
05/27/1997 |
SMITH & NEPHEW SUTURE COLLET |
SMITH & NEPHEW ENDOSCOPY, INC. |
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