Medical Device Manufacturer · US , Sacramento , CA

Hayes Medical, Inc. - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 1995

Recent clearances: CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI, PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT

12

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hayes Medical, Inc. Orthopedic ✕

12 devices

1-12 of 12

Cleared Jan 31, 2007

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT

Orthopedic · 26d

Cleared Dec 21, 2006

UNISYN HA PLASMA MODULAR HIP

Orthopedic · 128d

Cleared Apr 28, 2006

CONSENSUS ACETABULAR SHELL SYSTEM

Orthopedic · 49d

Cleared Apr 10, 2003

CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM

Orthopedic · 85d

Cleared Apr 01, 2003

CONSENSUS UNIPOLAR HEAD, COCR

Orthopedic · 70d

Cleared Jul 24, 2002

CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE

Orthopedic · 78d

Cleared Apr 15, 2002

CONSENSUS ACETABLAR SHELL, TI COATED

Orthopedic · 89d

Cleared Feb 23, 2001

TRITON HIP SYSTEM

Orthopedic · 88d

Cleared Aug 07, 2000

CONSENSUS KNEE SYSTEM

Orthopedic · 90d

Cleared Nov 25, 1998

CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI

Orthopedic · 89d

Cleared Jan 27, 1997

PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT

Orthopedic · 84d

Cleared Nov 24, 1995

CORTICELLOUS BONE SCREW

Orthopedic · 141d