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
Dec 27, 1985
LINK CANCELLOUS SCREWS
Link America, Inc.
Orthopedic
24d
Cleared
Dec 27, 1985
LINK CORTICAL SCREWS
Link America, Inc.
Orthopedic
24d
Cleared
Dec 09, 1985
TITANIUIM BONE SCREW
George Tiemann & Co.
Orthopedic
83d
Cleared
May 22, 1985
FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
Warsaw Orthopedic, Inc.
Orthopedic
14d
Cleared
May 20, 1985
ORTHOPEDIC IMPLANT SCREWS
Kirkstil Corp., Inc.
Orthopedic
137d
Cleared
Apr 22, 1985
T-SCREW
Northeast Iowa Podiatry
Orthopedic
27d
Cleared
Apr 19, 1985
INTERMEDICS BONE SCREW
Intermedics Orthopedics
Orthopedic
53d
Cleared
Aug 12, 1983
BONE SCREW
W.L. Gore & Associates, Inc.
Orthopedic
60d
Cleared
Mar 11, 1981
BONE FIXACTION SCREW
Serrano Intl.
Orthopedic
15d
Cleared
Feb 09, 1981
MECRON CANCELLOUS CANNULATED BONE SCREWS
Serrano Intl.
Orthopedic
14d
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
Cleared
Jan 14, 1977
SCREW, WADSWORTH OLECRANON
Orthopedic Equipment Co., Inc.
Orthopedic
4d