FDA 510(k) Applications Submitted by SHAWN T HUXEL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090128 |
01/21/2009 |
TAC-TITE (TM) |
CORE ESSENCE ORTHOPAEDICS, INC. |
| K040199 |
01/29/2004 |
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS |
OSSEUS, LLC |
| K171004 |
04/04/2017 |
Hintermann Series H2 Total Ankle System |
Dt MedTech LLC |
| K081060 |
04/14/2008 |
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 |
CORE ESSENCE ORTHOPAEDICS, LLC |
| K071477 |
05/29/2007 |
REVERTO 55 AND 37 SHAPE MEMORY STAPLES |
CORE ESSENCE ORTHOPAEDICS, LLC |
| K071520 |
06/04/2007 |
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X |
CORE ESSENCE ORTHOPAEDICS, LLC |
| K023564 |
10/23/2002 |
OSSE-LIGN |
OSSEUS, LLC |
| K043339 |
12/03/2004 |
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG |
XTREMI-T, LLC |
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