FDA 510(k) Applications Submitted by TEFFANY HUTTO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070050 |
01/04/2007 |
VITALITY HIP SYSTEM MODEL#420 |
ENCORE MEDICAL, L.P. |
| K130048 |
01/08/2013 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK |
ENCORE MEDICAL, L.P. |
| K190057 |
01/11/2019 |
DJO Acetabular System |
Encore Medical, L.P. |
| K140130 |
01/17/2014 |
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED |
ENCORE MEDICAL, L.P. |
| K070221 |
01/24/2007 |
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 |
ENCORE MEDICAL, L.P. |
| K120241 |
01/27/2012 |
LINEAR HIP STEM, SIZE 5 |
ENCORE MEDICAL, L.P. |
| K160342 |
02/08/2016 |
EMPOWR PS Knee System |
Encore Medical, L.P. |
| K190290 |
02/11/2019 |
AltiVate Reverse Humeral Stem, 48mm |
Encore Medical, L.P. |
| K130365 |
02/13/2013 |
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER |
ENCORE MEDICAL, L.P. |
| K080402 |
02/14/2008 |
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 |
ENCORE MEDICAL, L.P. |
| K100741 |
03/16/2010 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 |
ENCORE MEDICAL, L.P. |
| K140830 |
04/02/2014 |
EXPRT REVISION KNEE |
ENCORE MEDICAL, L.P. |
| K140904 |
04/09/2014 |
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 |
ENCORE MEDICAL, L.P. |
| K180930 |
04/10/2018 |
EMPOWR VVC TIBIAL INSERT |
Encore Medical, L.P. |
| K111061 |
04/18/2011 |
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) |
ENCORE MEDICAL, L.P. |
| K191325 |
05/16/2019 |
EMPOWR Partial Knee |
Encore Medical, L.P. |
| K081448 |
05/23/2008 |
ENCORE SHOULDER REVISION GLENOID |
ENCORE MEDICAL, L.P. |
| K161610 |
06/10/2016 |
EXPRT Revision Hip System |
Encore Medical, L.P. |
| K111629 |
06/13/2011 |
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 |
ENCORE MEDICAL, L.P. |
| K081679 |
06/17/2008 |
REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 |
ENCORE MEDICAL, L.P. |
| K111735 |
06/21/2011 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER |
ENCORE MEDICAL, L.P. |
| K161945 |
07/15/2016 |
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) |
ENCORE MEDICAL, L.P. |
| K141990 |
07/22/2014 |
ENCORE HUMERAL SHOULDER STEM |
ENCORE MEDICAL, L.P. |
| K122239 |
07/27/2012 |
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING |
ENCORE MEDICAL, L.P. |
| K072154 |
08/03/2007 |
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM |
ENCORE MEDICAL, L.P. |
| K172351 |
08/03/2017 |
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert |
Encore Medical, L.P. |
| K092331 |
08/04/2009 |
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; |
ENCORE MEDICAL, L.P. |
| K082398 |
08/20/2008 |
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS |
ENCORE MEDICAL, L.P. |
| K122636 |
08/29/2012 |
REVELATION POROUS COATED HIP STEM, SIZE 8 |
ENCORE MEDICAL, L.P. |
| K172651 |
09/05/2017 |
FMP Extended Liners |
Encore Medical, L.P. |
| K092873 |
09/18/2009 |
REVERSE SHOULDER PROSTHESIS |
DJO SURGICAL |
| K082844 |
09/26/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE |
ENCORE MEDICAL, L.P. |
| K173073 |
09/29/2017 |
AltiVate Anatomic to Reverse Conversion Module |
Encore Medical, L.P. |
| K203026 |
10/02/2020 |
AltiVate« Anatomic Pegged Glenoid with Markers |
Encore Medical, L.P. |
| K063257 |
10/27/2006 |
FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT |
ENCORE MEDICAL, L.P. |
| K103208 |
11/01/2010 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM |
ENCORE MEDICAL, L.P. |
| K063406 |
11/09/2006 |
ENCORE KNEE SYSTEM IFU |
ENCORE MEDICAL, L.P. |
| K143242 |
11/12/2014 |
Rebel 3DKNEE System |
ENCORE MEDICAL, L.P. |
| K063414 |
11/13/2006 |
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 |
ENCORE MEDICAL, L.P. |
| K193226 |
11/22/2019 |
AltiVate Anatomic Canal-Sparing (CS) Shoulder |
Encore Medical, L.P |
| K173723 |
12/05/2017 |
EMPOWR Universal Tibial Baseplate |
Encore Medical, L.P. |
| K203557 |
12/07/2020 |
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing |
Encore Medical, L.P. |
| K083651 |
12/09/2008 |
REVELATION STEM, MODEL 427-21/42-080/180 |
ENCORE MEDICAL, L.P. |
| K163497 |
12/13/2016 |
EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt |
ENCORE MEDICAL, L.P. |
| K113756 |
12/21/2011 |
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA |
ENCORE MEDICAL, L.P. |
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