FDA 510(k) Applications Submitted by Vladislava Zaitseva
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110197 |
01/24/2011 |
EXACTECH GIBRALT SPINAL SYSTEM |
EXACTECH, INC. |
| K150438 |
02/19/2015 |
Force Fiber OrthoTape suture |
TELEFLEX MEDICAL, INC. |
| K121684 |
06/07/2012 |
NOVATION LPI PRIME FEMORAL STEM |
EXACTECH, INC. |
| K121877 |
06/28/2012 |
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES |
EXACTECH, INC. |
| K172016 |
07/03/2017 |
Force Fiber Fusion Suture |
Teleflex Medical Incorporated |
| K112097 |
07/22/2011 |
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 |
EXACTECH, INC. |
| K102487 |
08/30/2010 |
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 |
EXACTECH, INC. |
| K102870 |
09/30/2010 |
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM |
EXACTECH, INC. |
| K102975 |
10/06/2010 |
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE |
EXACTECH, INC. |
| K113320 |
11/10/2011 |
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 |
EXACTECH, INC. |
| K113609 |
12/06/2011 |
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 |
EXACTECH, INC. |
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