Medical Device Manufacturer · US , Hunt Valley , MD

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

21 submissions · 20 cleared · Since 1996

Recent clearances: Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED, OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM, OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

21

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osteoimplant Technology, Inc. Orthopedic ✕

21 devices

1-12 of 21

Cleared Jan 25, 2005

Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED

Orthopedic · 315d

Cleared Nov 16, 2004

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

Orthopedic · 168d

Cleared May 06, 2004

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

Orthopedic · 94d

Cleared Dec 03, 2003

Z-SERIES MODULAR TOTAL HIP SYSTEM

Orthopedic · 91d

Cleared Jun 12, 2003

OTI BONE CEMENT PLUG

Orthopedic · 106d

Cleared Nov 20, 2002

OTI UNICONDULAR INTERPOSITIONAL SPACER

Orthopedic · 90d

Cleared Jul 23, 2002

R120 MODULAR TOTAL HIP SYSTEM

Orthopedic · 49d

Cleared Dec 11, 2001

MJS POSTERIOR STABILIZED KNEE SYSTEM

Orthopedic · 116d

Cleared Sep 05, 2001

R120 MODULAR TOTAL HIP SYSTEM

Orthopedic · 90d

Cleared Jan 19, 2001

OTI CERAMIC FEMORAL HEAD SYSTEM

Orthopedic · 88d

Cleared Jan 10, 2001

TRIAD II MODULAR TOTAL HIP SYSTEM

Orthopedic · 90d

Cleared Jun 08, 2000

OMEGA II MODULAR TOTAL HIP SYSTEM

Orthopedic · 87d