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., Synthes (Usa) and Wrightmedicaltechnologyinc.
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
Dec 06, 1989
EXACTECH BONE SCREW
Exactech, Inc.
Orthopedic
15d
Cleared
Nov 24, 1989
DEPUY (TM) TRUE COMPRESSION SCREW
Depuy, Inc.
Orthopedic
86d
Cleared
Nov 08, 1989
ASNIS II GUIDED BONE SCREW
Howmedica Corp.
Orthopedic
43d
Cleared
Aug 21, 1989
DEPUY CANNULATED BONE SCREW
Depuy, Inc.
Orthopedic
108d
Cleared
Aug 07, 1989
VECSEI EXPANDING SCREW
Howmedica Corp.
Orthopedic
108d
Cleared
Dec 18, 1986
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
Howmedica Corp.
Orthopedic
23d
Cleared
Dec 06, 1979
SEIDEL INTRAMEDULLARY PLUG
Howmedica Corp.
Orthopedic
34d
Cleared
Oct 26, 1979
HERBERT BONE SCREW
Zimmer, Inc.
Orthopedic
17d
Cleared
Feb 23, 1978
ORTHOPEDIC DEVICES
Biomet, Inc.
Orthopedic
10d