HWC · Class II · 21 CFR 888.3040

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
217–240 of 1064
Cleared Aug 07, 2017
FuzeFix Screw System
K170038
Fusion Orthopedics, LLC
Orthopedic · 214d
Cleared Jul 14, 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
K162153
Ascension Orthopedics
Orthopedic · 346d
Cleared Jul 13, 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018
Extremity Medical, LLC
Orthopedic · 99d
Cleared Jul 07, 2017
Hammertoe Correction System
K171448
Life Spine, Inc.
Orthopedic · 51d
Cleared Jun 27, 2017
Cannulated Screws Neoortho
K162874
Neoortho Produtos Ortopedicos S/A
Orthopedic · 257d
Cleared Jun 20, 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571
Tyber Medical, LLC
Orthopedic · 113d
Cleared Jun 09, 2017
2-Piece Hammertoe Correction System
K162685
Life Spine, Inc.
Orthopedic · 256d
Cleared Jun 06, 2017
Flower Bone Screw Set
K170687
Flower Orthopedics Corporation
Orthopedic · 91d
Cleared May 31, 2017
ALLY(TM) Bone Screws
K170698
Providence Medical Technology, Inc.
Orthopedic · 85d
Cleared May 22, 2017
SMV Scientific Cannulated Screws
K170021
Smv Scientific
Orthopedic · 139d
Cleared May 11, 2017
Arthrex Compression Screws
K170382
Arthrex, Inc.
Orthopedic · 93d
Cleared May 10, 2017
I.B.S. osteosynthesis screws
K170594
In2bones Sas
Orthopedic · 71d
Cleared May 01, 2017
CAPTIVATE™ Compression Screws
K162825
Globus Medical, Inc.
Orthopedic · 206d
Cleared Apr 26, 2017
HV Screw System
K170889
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared Apr 24, 2017
Foot and Hand Motion
K170012
Newclip Technics
Orthopedic · 111d
Cleared Apr 13, 2017
MICATM Screw System
K162353
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Apr 04, 2017
OsteoMed ExtremiFix Mid and Large Screw System
K163303
Osteomed, LLC
Orthopedic · 133d
Cleared Apr 04, 2017
BePOD Cannulated Arthrodesis Screws
K170040
Fournitures Hospitalieres Industrie
Orthopedic · 89d
Cleared Mar 08, 2017
OrthoSolutions 'System26' Bone Screws
K163489
Ortho Solutions UK Limited
Orthopedic · 86d
Cleared Mar 03, 2017
ToeMATE® Hammertoe Correction System
K170350
Arthrosurface, Inc.
Orthopedic · 28d
Cleared Feb 28, 2017
EPIC Extremity Snap-Off Screw
K163038
Epic Extremity, LLC
Orthopedic · 120d
Cleared Feb 21, 2017
SurgTech Trauma System
K161894
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
K161616
Synthes USA Products, LLC
Orthopedic · 248d
Cleared Feb 09, 2017
RASL Repair Kit
K161334
Radicle Orthopaedics, Inc.
Orthopedic · 273d