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
Jan 18, 2017
GEO Bone Screw System
Gramercy Extremity Orthopeidics, LLC
Orthopedic
191d
Cleared
Dec 19, 2016
KLS Martin Cannulated Headless Screws
KLS-Martin L.P.
Orthopedic
229d
Cleared
Dec 05, 2016
4.0 and 6.5 Cancellous Bone Screw and Washer
Smv Scientific
Orthopedic
244d
Cleared
Nov 22, 2016
ToeTac™ 10° Hammertoe Fixation System
Restore Surgical, LLC Dba Instratek
Orthopedic
146d
Cleared
Nov 16, 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
Tyber Medical, LLC
Orthopedic
160d
Cleared
Nov 15, 2016
AmorChem Titanium Porous Fixation Device
Amorchem Holdings, Inc.
Orthopedic
237d
Cleared
Oct 11, 2016
HammerTech Fixation System
Fusion Orthopedics, LLC
Orthopedic
139d
Cleared
Oct 06, 2016
I.B.S. 2.0 Osteosynthesis screw
In2bones Sas
Orthopedic
253d
Cleared
Aug 01, 2016
The Hammertoe Correction System
Life Spine, Inc.
Orthopedic
284d
Cleared
Jul 29, 2016
Cannulated Screw
Miami Device Solutions, LLC
Orthopedic
105d
Cleared
Jun 30, 2016
Arthrosurface Bone Screws
Arthrosurface, Inc.
Orthopedic
27d
Cleared
Jun 23, 2016
The Life Spine Subtalar Implant System
Life Spine
Orthopedic
148d
Cleared
Jun 03, 2016
dynaMX(TM) Nitinol Compression Screw
Mx Orthopedics, Corp.
Orthopedic
108d
Cleared
Jun 03, 2016
Large Screws Range
Newclip Technics
Orthopedic
92d
Cleared
Apr 29, 2016
OsteoBullet Compression Screw
Phalanx Innovations
Orthopedic
85d
Cleared
Apr 29, 2016
MC-Subtalar(TM) II
Merete Medical GmbH
Orthopedic
60d
Cleared
Apr 19, 2016
Bicortical Fixation Screw & Washer Nut System
First Ray, LLC
Orthopedic
123d
Cleared
Mar 28, 2016
SMV Scientific Schanz Screws
Smv Scientific
Orthopedic
26d
Cleared
Mar 09, 2016
Biomet Variable Pitch Compression Screw System
Biomet, Inc.
Orthopedic
57d
Cleared
Mar 02, 2016
RECON system - Compression Screws
Normed Medizin-Technik GmbH
Orthopedic
252d
Cleared
Feb 26, 2016
Tyber Medical Trauma Screw
Tyber Medical, LLC
Orthopedic
73d
Cleared
Feb 25, 2016
SIGN Compression Screw System
Sign Fracture Care International
Orthopedic
57d
Cleared
Feb 12, 2016
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
Merete Medical GmbH
Orthopedic
191d
Cleared
Feb 05, 2016
MINIARS SCREWS
Overmed Srl.
Orthopedic
414d