Medical Device Manufacturer · US , Indianapolis , IN

Turnkey Intergration USA, Inc. - FDA 510(k) Cleared Devices

26 submissions · 23 cleared · Since 1990
26
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Turnkey Intergration USA, Inc. Orthopedic
24 devices
1-24 of 24
Cleared Jun 29, 1999
OMNI-FIX, HUMERAL NAIL
K991405 · KTW
Orthopedic · 68d
Cleared Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
K990523 · LPH
Orthopedic · 70d
Cleared Apr 01, 1999
OMNI-FIX, NAIL SYSTEM
K990307 · KTW
Orthopedic · 59d
Cleared Aug 29, 1997
LINK CEMENT PLUG
K972411 · LZN
Orthopedic · 64d
Cleared Apr 21, 1997
ARTOS, DIPLOS SYSTEM
K970284 · KWY
Orthopedic · 87d
Cleared Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
K970084 · JDQ
Orthopedic · 63d
Cleared Nov 06, 1995
LUBINUS SP II HIP SYSTEM
K953653 · JDG
Orthopedic · 95d
Cleared Jul 05, 1995
LINK ENDO MODEL REVISION CUP
K943986 · HRS
Orthopedic · 323d
Cleared May 25, 1995
LINK SADDLE PROTHESIS
K951355 · KWL
Orthopedic · 78d
Cleared Feb 06, 1995
UNIVERSAL WRIST
K940297 · JWI
Orthopedic · 381d
Cleared Oct 07, 1994
NUFFIELD TOTAL KNEE
K931960 · JWH
Orthopedic · 534d
Cleared Apr 14, 1993
INTRINSIC STEM
K923911 · LWJ
Orthopedic · 253d
Cleared Nov 04, 1992
C-FIT CEMENTED HIP STEM
K923898 · JDI
Orthopedic · 92d
Cleared Jan 27, 1992
VENUS HIP
K913708 · LWJ
Orthopedic · 164d
Cleared Dec 24, 1991
LIMA 28MM CERAMIC HEAD, MODIFICATION
K912985 · LZO
Orthopedic · 175d
Cleared Oct 21, 1991
LIMA RPS SHOULDER
K913282 · HSD
Orthopedic · 89d
Cleared Sep 06, 1991
MAY HUMERUS PLATES
K912936 · HRS
Orthopedic · 63d
Cleared Jun 28, 1991
LIMA CEMENT RESTRICTOR
K911338 · JDK
Orthopedic · 94d
Cleared Apr 12, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
K910547 · LZO
Orthopedic · 64d
Cleared Apr 09, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
K910548 · LZO
Orthopedic · 61d
Cleared Mar 12, 1991
Q SYSTEM 28 HIP STEM
K910010 · LWJ
Orthopedic · 69d
Cleared Nov 26, 1990
VSP HIP STEM
K903957 · JDI
Orthopedic · 90d
Cleared Aug 22, 1990
MODIFIED FREEMAN ACETABULAR CUP
K902110 · KWA
Orthopedic · 105d
Cleared Aug 22, 1990
MODIFIED FREEMAN REVISION ACETABULAR CUP
K902111 · KWA
Orthopedic · 105d
Filters