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).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Jul 15, 2015
OsteoMed Cannulated Screw System
Osteomed Corp.
Orthopedic
90d
Cleared
Jul 15, 2015
Monster Screw System
Paragon 28
Orthopedic
48d
Cleared
Jun 23, 2015
SMV Scientific Bone Screws
Smv Scientific
Orthopedic
70d
Cleared
Jun 12, 2015
Sonoma Cancellous Bone Screw and Washer
Sonoma Orthopedics Products, Inc.
Orthopedic
119d
Cleared
Jun 04, 2015
ToeTac Hammertoe Fixation System
Restore Surgical, LLC Dba Instratek
Orthopedic
104d
Cleared
May 26, 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
Biomet Microfixation
Orthopedic
25d
Cleared
May 15, 2015
Arthrex RetroFusion Screw
Arthrex, Inc.
Orthopedic
23d
Cleared
May 11, 2015
Life Spine Cannulated Screws
Life Spine, Inc.
Orthopedic
111d
Cleared
May 08, 2015
Subtalar Spacer System (STS)
Wrightmedicaltechnologyinc
Orthopedic
98d
Cleared
May 08, 2015
Snap-Off Self-Compressive Screw
Neosteo
Orthopedic
45d
Cleared
Apr 29, 2015
SMV Scientific 4.5 mm Bone Screws
Summit Medventures
Orthopedic
92d
Cleared
Apr 29, 2015
PHALINX Hammertoe System
Wrightmedicaltechnologyinc
Orthopedic
85d
Cleared
Apr 29, 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
Aap Implantate AG
Orthopedic
16d
Cleared
Mar 31, 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
Zimmer, Inc.
Orthopedic
148d
Cleared
Mar 23, 2015
Flow-Screw
Flow-Fx, LLC
Orthopedic
178d
Cleared
Mar 04, 2015
Extremity Medical Calcaneal Osteotomy Device
Extremity Medical, LLC
Orthopedic
23d
Cleared
Feb 20, 2015
EASY OUT
Feet For Life Podiatry Center
Orthopedic
268d
Cleared
Feb 06, 2015
Nexis osteosynthesis snap-off screws
Novastep
Orthopedic
95d
Cleared
Feb 06, 2015
Nexis osteosynthesis compressive screws
Novastep
Orthopedic
88d
Cleared
Feb 04, 2015
Extremity Medical Calcaneal Osteotomy Device
Extremity Medical, LLC
Orthopedic
68d
Cleared
Jan 23, 2015
Cannulated Screw System
Wrightmedicaltechnologyinc
Orthopedic
50d
Cleared
Jan 16, 2015
CrossRoads Screw System
Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem
Orthopedic
86d
Cleared
Jan 16, 2015
Arthrex Low Profile Screws
Arthrex, Inc.
Orthopedic
28d
Cleared
Jan 13, 2015
INFIX CANNULATED SCREW SYSTEM
Infix Medical, LLC
Orthopedic
168d