Medical Device Manufacturer · US , Braintree , MA

Johnson & Johnson Orthopaedics, Inc. - FDA 510(k) Cleared Devices

22 submissions · 19 cleared · Since 1990
22
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Johnson & Johnson Orthopaedics, Inc. Orthopedic
21 devices
1-21 of 21
Cleared Dec 06, 1994
PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
K931466 · JWH
Orthopedic · 622d
Cleared Oct 06, 1994
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K935452 · LZO
Orthopedic · 328d
Cleared Sep 29, 1994
ULTIMA UNIPOLAR MODULAR HEAD
K940190 · KWL
Orthopedic · 259d
Cleared Sep 28, 1994
P.F.C. CERAMIC HIP HEAD
K933275 · LZO
Orthopedic · 449d
Cleared Sep 20, 1994
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
K932595 · LZN
Orthopedic · 480d
Cleared Jun 09, 1994
P.F.C. BIPOLAR HIP SYSTEM
K931655 · KWY
Orthopedic · 430d
Cleared Jun 06, 1994
UNIVERSAL INSET PATELLA
K933867 · JWH
Orthopedic · 301d
Cleared Jun 03, 1994
P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
K935262 · JWH
Orthopedic · 212d
Cleared Feb 09, 1994
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
K931189 · LZO
Orthopedic · 337d
Cleared Jan 25, 1994
P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT
K924340 · JWH
Orthopedic · 515d
Cleared Jan 25, 1994
TRICK MODULAR KNEE TIBIAL TRAY-POROUS
K931054 · JWH
Orthopedic · 330d
Cleared Oct 04, 1993
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR
K930712 · LZO
Orthopedic · 235d
Cleared Feb 12, 1993
ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
K924379 · KWL
Orthopedic · 165d
Cleared Nov 24, 1992
ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS
K924115 · JDI
Orthopedic · 102d
Cleared Nov 13, 1991
JOHNSON AND JOHNSON POWER SYSTEM
K913629 · HSZ
Orthopedic · 90d
Cleared Oct 23, 1991
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL
K914439 · HSX
Orthopedic · 19d
Cleared Aug 26, 1991
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968 · HRY
Orthopedic · 173d
Cleared Jul 26, 1991
GROSS HIP FEMORAL COMPONENT
K904737 · JDI
Orthopedic · 281d
Cleared May 23, 1991
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
K910563 · JWH
Orthopedic · 104d
Cleared Oct 17, 1990
INSET PATELLAR COMPONENT
K904300 · JWH
Orthopedic · 28d
Cleared Jun 26, 1990
P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT
K902137 · JDI
Orthopedic · 46d
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