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
Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
Alphatec Mfg., Inc.
Orthopedic
79d
Cleared
May 01, 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
Concept, Inc.
Orthopedic
322d
Cleared
Feb 28, 1992
CORTICAL BONE SCREW
Dow Corning Wright
Orthopedic
81d
Cleared
Feb 14, 1992
AAP BONE SCREW
Aap International, Ltd.
Orthopedic
84d
Cleared
Feb 13, 1992
BONE SCREW 3.5 MM
Acu Med, Inc.
Orthopedic
59d
Cleared
Feb 11, 1992
UNIVERSAL COMPRESION SCREW
Howmedica Corp.
Orthopedic
90d
Cleared
Jan 24, 1992
M. KUROSAKA(TM) FIXATION SCREW
Depuy, Inc.
Orthopedic
189d
Cleared
Jan 13, 1992
OREGON FIXATION SCREW
Acu Med, Inc.
Orthopedic
312d
Cleared
Dec 19, 1991
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
Techmedica, Inc.
Orthopedic
31d
Cleared
Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
Alphatec Mfg., Inc.
Orthopedic
90d
Cleared
Nov 27, 1991
ACE CORTICAL BONE SCREW
Ace Medical Co.
Orthopedic
170d
Cleared
Nov 22, 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
Instrument Makar, Inc.
Orthopedic
199d
Cleared
Nov 22, 1991
OSTEO BONE SCREWS
Fred C. Bryson
Orthopedic
122d
Cleared
Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
Aesculap, Inc.
Orthopedic
90d
Cleared
Oct 04, 1991
AMSET(TM) BONE SCREW
Advanced Med/Surg, Inc.
Orthopedic
168d
Cleared
Aug 23, 1991
HUENE FIXATION SCREW
Acu Med, Inc.
Orthopedic
219d
Cleared
Jun 28, 1991
UNIVERSAL COMPRESSION SCREW
Howmedica Corp.
Orthopedic
247d
Cleared
Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
Howmedica Corp.
Orthopedic
90d
Cleared
Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
Ace Medical Co.
Orthopedic
83d
Cleared
Jan 04, 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
O'Tec Corp.
Orthopedic
37d
Cleared
Jan 04, 1991
CORTICAL BONE SCREW (EUROPEAN STYLE)
O'Tec Corp.
Orthopedic
37d
Cleared
Jan 04, 1991
CANCELLOUS SCREW
O'Tec Corp.
Orthopedic
37d
Cleared
Oct 16, 1990
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
Ace Medical Co.
Orthopedic
57d
Cleared
Oct 16, 1990
ACE CANNULATED CORTICAL BONE SCREW
Ace Medical Co.
Orthopedic
57d