Medical Device Manufacturer · US , Indianapolis , IN

Protek, Inc. - FDA 510(k) Cleared Devices

25 submissions · 20 cleared · Since 1985

Total

Cleared

Denied

Protek, Inc. has 20 FDA 510(k) cleared orthopedic devices. Based in Indianapolis, US.

Historical record: 20 cleared submissions from 1985 to 1989.

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 - Protek, Inc.

25 devices

1-12 of 25

Cleared Aug 09, 1989

ARC-2F ACETABULAR CUP

K893785 · LWJ

Orthopedic · 79d

Cleared Jul 25, 1989

P.S.A. FEMORAL HIP PROSTHESIS

K893959 · KWY

Orthopedic · 54d

Cleared Jul 19, 1989

FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR

K892059 · LZY

Orthopedic · 112d

Cleared May 26, 1989

RESUBMITTED CLW ACETABULAR CUP W/SULMESH

K883794 · LWJ

Orthopedic · 261d

Cleared May 10, 1989

VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC

K884952 · LZO

Orthopedic · 162d

Cleared Feb 27, 1989

MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

K884889 · KWL

Orthopedic · 97d

Cleared Feb 08, 1989

NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI

K884789 · KWL

Orthopedic · 85d

Cleared Feb 08, 1989

M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.

K890054 · JDI

Orthopedic · 33d

Cleared Dec 29, 1988

MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS

K884888 · JDI

Orthopedic · 37d

Cleared Oct 20, 1988

SAMUELSON SCREWLOC CUP

K882671 · KWA

Orthopedic · 114d

Cleared Jan 27, 1988

SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP

K874093 · JDI

Orthopedic · 111d

Cleared Oct 28, 1987

C.L.E. ACETABULAR CUP

K870922 · JDI

Orthopedic · 239d

Protek, Inc. - FDA 510(k) Cleared Devices

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