Osteonics Corp. - FDA 510(k) Cleared Devices

Cleared Jan 14, 1988

OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.

K872768 · KWA

Orthopedic · 184d

Cleared Dec 29, 1987

OMNIFIT DISTAL STEM CEMENT SPACERS

K872528 · JDK

Orthopedic · 187d

Cleared Sep 18, 1987

OMNIFIT BONE SCREW

K873251 · HWC

Orthopedic · 32d

Cleared Jun 02, 1987

OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)

K871769 · JWH

Orthopedic · 27d

Cleared May 29, 1987

OMNIFIT II HIP PROSTHESES: CEMENT FIXATION

K870235 · JDI

Orthopedic · 128d

Cleared Mar 20, 1987

MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS

K870216 · JDI

Orthopedic · 59d

Cleared Dec 22, 1986

OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

K862837 · HSX

Orthopedic · 150d

Cleared Dec 19, 1986

OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM

K863668 · JWH

Orthopedic · 92d

Cleared Nov 25, 1986

OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE

K864372

Orthopedic · 20d

Cleared Sep 02, 1986

OSTEONICS SHOULDER PROSTHESIS

K862535 · KWS

Orthopedic · 62d

Cleared Jun 27, 1986

OSTEONICS ELBOW PROSTHESIS

K861680 · JDC

Orthopedic · 57d

Cleared Jun 09, 1986

(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT

K861723 · KWA

Orthopedic · 34d

Cleared Mar 14, 1986

M.C.R. KNEE PROSTHESIS (SERIES 3000)

K860654 · JWH

Orthopedic · 21d

Cleared Jul 30, 1985

NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS

K844818 · KWL

Orthopedic · 231d

Cleared Jun 18, 1985

OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES

K851404 · KWA

Orthopedic · 70d

Cleared Apr 25, 1985

MICRO-STRUC. ACETABULAR COMPON- MC2P

K850352 · JDL

Orthopedic · 87d

Cleared Mar 12, 1985

MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM

K844817 · JDI

Orthopedic · 91d

Cleared Jan 27, 1984

MICRO-STRUCTURED HS2P HIP STEMS

K833970 · LWJ

Orthopedic · 72d

Cleared Dec 27, 1983

HS4 HEAD/NECK FEMORAL PROSTHESES

K833461

Orthopedic · 83d

Cleared Sep 15, 1983

MICRO-STRUCTURED SURFACE HIP PROSTHESIS

K831708

Orthopedic · 81d

Cleared Jan 17, 1983

HC 1M METALBACKED ACETABULAR CUP

K823419 · JDI

Orthopedic · 63d

Cleared Oct 20, 1981

HIP STEM SYSTEM TITANIUM ALLOY

K812801 · JDI

Orthopedic · 14d

Cleared Jun 18, 1981

COLBALT ALLOY ORTHOPAEDIC WIRE

K811500 · JDR

Orthopedic · 22d

Cleared Jan 23, 1981

PROSTHESIS, HIP FEMORAL COMPONENT METAL

K803191 · KWL

Orthopedic · 38d

Cleared Jan 23, 1981

HCL ACETABULAR COMPONENTS

K803192 · KWZ

Orthopedic · 38d