Medical Device Manufacturer · US , Timonium , MD

Osteo Technology, Inc.

18 submissions · 17 cleared · Since 1992
18
Total
17
Cleared
0
Denied

Osteo Technology, Inc. — FDA 510(k) Submissions

Osteo Technology, Inc. has submitted 18 FDA 510(k) premarket notifications since 1992, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component), Antiserum, Cf, Rubeola, Pin, Fixation, Smooth . Use the specialty filter in the sidebar to narrow results.

18 devices
1–12 of 18
REPLICA(TM) TOTAL HIP SYSTEM
K926156 · LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · Orthopedic
Mar 1994 457d
ANATOMICAL TYPE KNEE SYSTEM
K922859 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · Orthopedic
Sep 1993 476d
TOTAL CONDYLAT TYPE KNEE SYSTEM
K922869 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · Orthopedic
Jul 1993 404d
OTI ORTHOPEDIC WIRE SYSTEM
K925447 · JDQ Cerclage, Fixation · Orthopedic
Jun 1993 244d
MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
K926213 · HSB Rod, Fixation, Intramedullary And Accessories · Orthopedic
Jun 1993 189d
BIOMETRIC SCREW FIXATION CUP
K922861 · JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) · Orthopedic
May 1993 342d
THREE SPIKE CUP
K922870 · GRF Antiserum, Cf, Rubeola · Microbiology
Apr 1993 308d
AMERICANA HIP PROTHESIS
K922682 · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal · Orthopedic
Mar 1993 285d
OTI ORTHOPEDIC FASTENER SYSTEM
K925301 · HTY Pin, Fixation, Smooth · Orthopedic
Mar 1993 146d
AUSTIN-MOORE TYPE HIP PROSTHESIS
K922860 · JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · Orthopedic
Feb 1993 253d
CHARNLEY TYPE HIP PROTHESIS
K922862 · JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · Orthopedic
Feb 1993 253d
EUROSTEM HIP PROTHESIS SYSTEM
K922863 · JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · Orthopedic
Feb 1993 253d
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