Medical Device Manufacturer · US , Oberlin , KS

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

23 submissions · 18 cleared · Since 1988

Total

Cleared

Denied

O'Tec Corp. has 18 FDA 510(k) cleared orthopedic devices. Based in Oberlin, US.

Historical record: 18 cleared submissions from 1988 to 1994.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - O'Tec Corp.

23 devices

1-23 of 23

Cleared Aug 19, 1994

SCC22/ SCC26 SHOWER COMMODE CHAIR

K943293 · IOR

Physical Medicine · 42d

Cleared Jul 01, 1991

FUTURA FEMORAL HIP STEM

K910093 · JDI

Orthopedic · 174d

Cleared Jan 04, 1991

U.S. TYPE CRUCIATE SLOT BONE SCREW

BROAD SELF-COMPRESSING PLATE

K905355 · HRS

Orthopedic · 37d

Cleared Jan 04, 1991

CORTICAL BONE SCREW (EUROPEAN STYLE)

THOMPSON TYPE HIP PROSTHESIS

K905334 · KWL

Orthopedic · 13d

Cleared Dec 11, 1990

STEINMAN PIN, THREADED

HANSEN-STREET TYPE INTRAMEDULLARY NAIL

K905348 · KTW

Orthopedic · 13d

Cleared Dec 11, 1990

AUSTIN MOORE TYPE HIP PROTHESIS

Physical Medicine · 14d

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

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