Medical Device Manufacturer · US , Sacramento , CA

Hayes Medical, Inc.

12 submissions · 11 cleared · Since 1995
12
Total
11
Cleared
0
Denied

Hayes Medical, Inc. — FDA 510(k) Submissions

Hayes Medical, Inc. has submitted 12 FDA 510(k) premarket notifications since 1995, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Hemi-, Femoral, Metal . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
K070061 · LWJ Prosthesis, Hip,... · Orthopedic
Jan 2007 26d
UNISYN HA PLASMA MODULAR HIP
K062383 · LWJ Prosthesis, Hip,... · Orthopedic
Dec 2006 128d
CONSENSUS ACETABULAR SHELL SYSTEM
K060635 · LPH Prosthesis, Hip,... · Orthopedic
Apr 2006 49d
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
K030151 · LZO Prosthesis, Hip,... · Orthopedic
Apr 2003 85d
CONSENSUS UNIPOLAR HEAD, COCR
K030205 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Apr 2003 70d
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2002 78d
CONSENSUS ACETABLAR SHELL, TI COATED
K020153 · LPH Prosthesis, Hip,... · Orthopedic
Apr 2002 89d
TRITON HIP SYSTEM
K003649 · LWJ Prosthesis, Hip,... · Orthopedic
Feb 2001 88d
CONSENSUS KNEE SYSTEM
K001456 · JWH Prosthesis, Knee,... · Orthopedic
Aug 2000 90d
CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
K983004 · JWH Prosthesis, Knee,... · Orthopedic
Nov 1998 89d
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395 · LZO Prosthesis, Hip,... · Orthopedic
Jan 1997 84d
CORTICELLOUS BONE SCREW
K953198 · HWC Screw, Fixation, Bone · Orthopedic
Nov 1995 141d
Filters
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