Medical Device Manufacturer · US , Austin , TX

Encore Medical, L.P. - FDA 510(k) Cleared Devices

81 submissions · 81 cleared · Since 2002
81
Total
81
Cleared
0
Denied
80 devices
51-75 of 80
Cleared Sep 16, 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET...
K111629 · PHX
Orthopedic · 95d
Cleared Jul 20, 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · PHX
Orthopedic · 93d
Cleared Jan 31, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · PHX
Orthopedic · 91d
Cleared Dec 21, 2010
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS
K103223 · OIY
Orthopedic · 50d
Cleared Sep 28, 2010
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
K091956 · OIY
Orthopedic · 454d
Cleared Aug 02, 2010
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS...
K100741 · PHX
Orthopedic · 139d
Cleared Jun 18, 2010
MOTIVATION KNEE SYSTEM
K100900 · JWH
Orthopedic · 79d
Cleared Mar 03, 2010
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200
K092331 · KWA
Orthopedic · 211d
Cleared Mar 13, 2009
REVELATION STEM, MODEL 427-21/42-080/180
K083651 · KWA
Orthopedic · 94d
Cleared Nov 25, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET...
K082844 · LZO
Orthopedic · 60d
Cleared Oct 15, 2008
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
K082398 · LZO
Orthopedic · 56d
Cleared Sep 30, 2008
ENCORE SHOULDER REVISION GLENOID
K081448 · MBF
Orthopedic · 130d
Cleared Aug 20, 2008
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679 · LPH
Orthopedic · 64d
Cleared Mar 28, 2008
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL...
K080402 · KWS
Orthopedic · 43d
Cleared Jan 10, 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED,...
K072888 · LPH
Orthopedic · 92d
Cleared Dec 14, 2007
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · LPH
Orthopedic · 133d
Cleared May 23, 2007
VITALITY HIP SYSTEM MODEL#420
K070050 · LPH
Orthopedic · 139d
Cleared Apr 04, 2007
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
K070221 · KWA
Orthopedic · 70d
Cleared Jan 08, 2007
ENCORE KNEE SYSTEM IFU
K063406 · JWH
Orthopedic · 60d
Cleared Dec 12, 2006
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34,...
K063414 · KWA
Orthopedic · 29d
Cleared Nov 22, 2006
FMP COATED SPIKED ACETABULAR CUP
K063257 · LPH
Orthopedic · 26d
Cleared May 27, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K051075 · PHX
Orthopedic · 30d
Cleared Mar 24, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K041066 · PHX
Orthopedic · 335d
Cleared Nov 04, 2004
METAL/METAL HIP SYSTEM
K040354 · KWA
Orthopedic · 266d
Cleared May 06, 2004
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K040397 · KWQ
Orthopedic · 79d

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