Medical Device Manufacturer · US , Hunt Valley , MD

Osteoimplant Technology, Inc. - FDA 510(k) Cleared Devices

21 submissions · 20 cleared · Since 1996
21
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteoimplant Technology, Inc. Orthopedic
21 devices
1-21 of 21
Cleared Jan 25, 2005
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
K040685 · LWJ
Orthopedic · 315d
Cleared Nov 16, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443 · LZO
Orthopedic · 168d
Cleared May 06, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K040225 · KWZ
Orthopedic · 94d
Cleared Dec 03, 2003
Z-SERIES MODULAR TOTAL HIP SYSTEM
K032729 · LPH
Orthopedic · 91d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608 · JDK
Orthopedic · 106d
Cleared Nov 20, 2002
OTI UNICONDULAR INTERPOSITIONAL SPACER
K022779 · HSH
Orthopedic · 90d
Cleared Jul 23, 2002
R120 MODULAR TOTAL HIP SYSTEM
K021822 · JDI
Orthopedic · 49d
Cleared Dec 11, 2001
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762 · HRY
Orthopedic · 116d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774 · JDI
Orthopedic · 90d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316 · LZO
Orthopedic · 88d
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199 · LPH
Orthopedic · 90d
Cleared Jun 08, 2000
OMEGA II MODULAR TOTAL HIP SYSTEM
K000817 · JDI
Orthopedic · 87d
Cleared Apr 08, 1999
OMEGA II MODULAR TOTAL HIP SYSTEM
K984227 · JDI
Orthopedic · 134d
Cleared Feb 24, 1999
J-SERIES OMEGA TOTAL HIP SYSTEM
K990003 · LPH
Orthopedic · 51d
Cleared Oct 05, 1998
OTI MODULAR SHOULDER SYSTEM
K982886 · HSD
Orthopedic · 49d
Cleared Oct 02, 1998
OTI FEMORAL LOCK TOTAL HIP SYSTEM
K982598 · JDI
Orthopedic · 70d
Cleared May 20, 1998
OMEGA HA COATED TOTAL HIP SYSTEM
K980981 · LPH
Orthopedic · 64d
Cleared Feb 27, 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
K974506 · LPH
Orthopedic · 88d
Cleared Jun 18, 1997
LSF TRIAD TOTAL HIP SYSTEM
K971020 · LPH
Orthopedic · 90d
Cleared Mar 07, 1997
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
K964924 · LPH
Orthopedic · 88d
Cleared Sep 17, 1996
OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS
K960647 · JDI
Orthopedic · 215d
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