FDA Product Code HWC: Screw, Fixation, Bone
FDA product code HWC covers bone fixation screws.
These implants are used to stabilize fractures, osteotomies, and bone grafts by compressing bone fragments together or anchoring plates and other fixation constructs. They are available in cortical, cancellous, and cannulated configurations for different anatomical sites and indications.
HWC devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., Wrightmedicaltechnologyinc and Synthes (Usa).
1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
Cleared
Aug 07, 2017
FuzeFix Screw System
Fusion Orthopedics, LLC
Orthopedic
214d
Cleared
Jul 14, 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
Ascension Orthopedics
Orthopedic
346d
Cleared
Jul 13, 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
Extremity Medical, LLC
Orthopedic
99d
Cleared
Jul 07, 2017
Hammertoe Correction System
Life Spine, Inc.
Orthopedic
51d
Cleared
Jun 27, 2017
Cannulated Screws Neoortho
Neoortho Produtos Ortopedicos S/A
Orthopedic
257d
Cleared
Jun 20, 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
Tyber Medical, LLC
Orthopedic
113d
Cleared
Jun 09, 2017
2-Piece Hammertoe Correction System
Life Spine, Inc.
Orthopedic
256d
Cleared
Jun 06, 2017
Flower Bone Screw Set
Flower Orthopedics Corporation
Orthopedic
91d
Cleared
May 31, 2017
ALLY(TM) Bone Screws
Providence Medical Technology, Inc.
Orthopedic
85d
Cleared
May 22, 2017
SMV Scientific Cannulated Screws
Smv Scientific
Orthopedic
139d
Cleared
May 11, 2017
Arthrex Compression Screws
Arthrex, Inc.
Orthopedic
93d
Cleared
May 10, 2017
I.B.S. osteosynthesis screws
In2bones Sas
Orthopedic
71d
Cleared
May 01, 2017
CAPTIVATE™ Compression Screws
Globus Medical, Inc.
Orthopedic
206d
Cleared
Apr 26, 2017
HV Screw System
Wrightmedicaltechnologyinc
Orthopedic
33d
Cleared
Apr 24, 2017
Foot and Hand Motion
Newclip Technics
Orthopedic
111d
Cleared
Apr 13, 2017
MICATM Screw System
Wrightmedicaltechnologyinc
Orthopedic
233d
Cleared
Apr 04, 2017
OsteoMed ExtremiFix Mid and Large Screw System
Osteomed, LLC
Orthopedic
133d
Cleared
Apr 04, 2017
BePOD Cannulated Arthrodesis Screws
Fournitures Hospitalieres Industrie
Orthopedic
89d
Cleared
Mar 08, 2017
OrthoSolutions 'System26' Bone Screws
Ortho Solutions UK Limited
Orthopedic
86d
Cleared
Mar 03, 2017
ToeMATE® Hammertoe Correction System
Arthrosurface, Inc.
Orthopedic
28d
Cleared
Feb 28, 2017
EPIC Extremity Snap-Off Screw
Epic Extremity, LLC
Orthopedic
120d
Cleared
Feb 21, 2017
SurgTech Trauma System
Surgtech, Inc.
Orthopedic
225d
Cleared
Feb 16, 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
Synthes USA Products, LLC
Orthopedic
248d
Cleared
Feb 09, 2017
RASL Repair Kit
Radicle Orthopaedics, Inc.
Orthopedic
273d