HWC · Class II · 21 CFR 888.3040

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
889–912 of 1064
Cleared Jun 28, 1991
UNIVERSAL COMPRESSION SCREW
K904809
Howmedica Corp.
Orthopedic · 247d
Cleared Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398
Howmedica Corp.
Orthopedic · 90d
Cleared Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
K905048
Ace Medical Co.
Orthopedic · 83d
Cleared Jan 04, 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
K905333
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
CORTICAL BONE SCREW (EUROPEAN STYLE)
K905357
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
CANCELLOUS SCREW
K905358
O'Tec Corp.
Orthopedic · 37d
Cleared Oct 16, 1990
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
K903810
Ace Medical Co.
Orthopedic · 57d
Cleared Oct 16, 1990
ACE CANNULATED CORTICAL BONE SCREW
K903811
Ace Medical Co.
Orthopedic · 57d
Cleared Aug 09, 1990
CANCELLOUS SCREW
K903253
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
HAGIE PIN
K903258
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
KNOWLES PIN
K903259
Onyx Medical Corp.
Orthopedic · 16d
Cleared Jul 30, 1990
LAG SCREW
K903244
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jun 20, 1990
CANNULATED INTERFERENCE SCREW SYSTEM
K901616
Smith & Nephew Dyonics, Inc.
Orthopedic · 75d
Cleared Mar 28, 1990
ACUFEX STERILE CANNULATED INTERFERENCE SCREW
K900132
Acufex Microsurgical, Inc.
Orthopedic · 77d
Cleared Jan 09, 1990
ACUFEX INTERFERENCE SCREW, STERILE
K895711
Acufex Microsurgical, Inc.
Orthopedic · 106d
Cleared Dec 06, 1989
EXACTECH BONE SCREW
K896601
Exactech, Inc.
Orthopedic · 15d
Cleared Nov 24, 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389
Depuy, Inc.
Orthopedic · 86d
Cleared Nov 09, 1989
CROSS CANCELLOUS BONE SCREW
K896044
Buckman Co., Inc.
Orthopedic · 23d
Cleared Nov 08, 1989
ASNIS II GUIDED BONE SCREW
K895766
Howmedica Corp.
Orthopedic · 43d
Cleared Sep 12, 1989
CORTICAL SCREW
K895217
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218
Orthopedic Systems, Inc.
Orthopedic · 25d
Cleared Sep 12, 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219
Orthopedic Systems, Inc.
Orthopedic · 25d