Medical Device Manufacturer · US , Timonium , MD

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

18 submissions · 17 cleared · Since 1992

Recent clearances: REPLICA(TM) TOTAL HIP SYSTEM, ANATOMICAL TYPE KNEE SYSTEM, TOTAL CONDYLAT TYPE KNEE SYSTEM

18

Total

17

Cleared

0

Denied

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

17 devices

1-17 of 17

Cleared Mar 09, 1994

REPLICA(TM) TOTAL HIP SYSTEM

Orthopedic · 457d

Cleared Sep 23, 1993

ANATOMICAL TYPE KNEE SYSTEM

Orthopedic · 476d

Cleared Jul 13, 1993

TOTAL CONDYLAT TYPE KNEE SYSTEM

Orthopedic · 404d

Cleared Jun 29, 1993

OTI ORTHOPEDIC WIRE SYSTEM

Orthopedic · 244d

Cleared Jun 17, 1993

MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM

Orthopedic · 189d

Cleared May 12, 1993

BIOMETRIC SCREW FIXATION CUP

Orthopedic · 342d

Cleared Mar 16, 1993

AMERICANA HIP PROTHESIS

Orthopedic · 285d

Cleared Mar 16, 1993

OTI ORTHOPEDIC FASTENER SYSTEM

Orthopedic · 146d

Cleared Feb 12, 1993

AUSTIN-MOORE TYPE HIP PROSTHESIS

Orthopedic · 253d

Cleared Feb 12, 1993

CHARNLEY TYPE HIP PROTHESIS

Orthopedic · 253d

Cleared Feb 12, 1993

EUROSTEM HIP PROTHESIS SYSTEM

Orthopedic · 253d

Cleared Feb 12, 1993

MUELLER TYPE FEMORAL STEM

Orthopedic · 253d

Cleared Feb 12, 1993

Orthopedic · 253d

Cleared Feb 12, 1993

THOMPSON TYPE HIP PROTHESIS

Orthopedic · 253d

Cleared Feb 12, 1993

UNIFIT FEMORAL STEM

Orthopedic · 253d

Cleared Jan 07, 1993

LSF ANATOMIC CEMENTED HIP

Orthopedic · 218d

Cleared Dec 10, 1992

NEER TYPE SHOULDER PROSTHESIS SYSTEM

Orthopedic · 189d