FDA 510(k) Applications Submitted by JULIE ACKER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090562 |
03/02/2009 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW, INC. |
| K211401 |
05/06/2021 |
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) |
Gyrus ACMI, Inc. |
| K101459 |
05/26/2010 |
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 |
SMITH & NEPHEW, INC. |
| K071586 |
06/11/2007 |
BIORAPTOR 2.3 PK SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K082215 |
08/06/2008 |
OSTEORAPTOR SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K092508 |
08/17/2009 |
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, |
SMITH & NEPHEW, INC. |
| K072322 |
08/20/2007 |
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS |
SMITH & NEPHEW, INC. |
| K073551 |
12/18/2007 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K093943 |
12/22/2009 |
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
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