Medical Device Manufacturer · US , Oberlin , KS

O'Tec Corp. - FDA 510(k) Cleared Devices

23 submissions · 18 cleared · Since 1988
23
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - O'Tec Corp. Orthopedic
21 devices
1-21 of 21
Cleared Jul 01, 1991
FUTURA FEMORAL HIP STEM
K910093 · JDI
Orthopedic · 174d
Cleared Jan 04, 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
K905333 · HWC
Orthopedic · 37d
Cleared Jan 04, 1991
HAGIE PIN
K905347 · JDW
Orthopedic · 37d
Cleared Jan 04, 1991
BROAD SELF-COMPRESSING PLATE
K905355 · HRS
Orthopedic · 37d
Cleared Jan 04, 1991
CORTICAL BONE SCREW (EUROPEAN STYLE)
K905357 · HWC
Orthopedic · 37d
Cleared Jan 04, 1991
CANCELLOUS SCREW
K905358 · HWC
Orthopedic · 37d
Cleared Dec 11, 1990
THOMPSON TYPE HIP PROSTHESIS
K905334 · KWL
Orthopedic · 13d
Cleared Dec 11, 1990
STEINMAN PIN, THREADED
K905336 · JDW
Orthopedic · 13d
Cleared Dec 11, 1990
STEINMAN PIN
K905337 · HTY
Orthopedic · 13d
Cleared Dec 11, 1990
SIDE PLATE
K905338 · KTT
Orthopedic · 13d
Cleared Dec 11, 1990
RUSH PIN
K905341 · HTY
Orthopedic · 13d
Cleared Dec 11, 1990
LAG SCREW
K905342 · KTT
Orthopedic · 13d
Cleared Dec 11, 1990
KNOWLES PIN
K905344 · JDW
Orthopedic · 13d
Cleared Dec 11, 1990
K-WIRE
K905345 · HTY
Orthopedic · 13d
Cleared Dec 11, 1990
JEWETT HIP NAIL
K905346 · KTT
Orthopedic · 13d
Cleared Dec 11, 1990
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K905348 · KTW
Orthopedic · 13d
Cleared Dec 11, 1990
AUSTIN MOORE TYPE HIP PROTHESIS
K905349 · KWL
Orthopedic · 13d
Cleared Dec 11, 1990
BLADE PLATE
K905352 · KTT
Orthopedic · 13d
Cleared Dec 11, 1990
BARBED SQUARE STAPLE
K905362 · JDR
Orthopedic · 13d
Cleared Dec 11, 1990
FIXATION STAPLE
K905363 · JDR
Orthopedic · 13d
Cleared Dec 11, 1990
ROUND STAPLE
K905364 · JDR
Orthopedic · 13d
Filters