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).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
985–1008 of 1070
Cleared Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
K922322
Alphatec Mfg., Inc.
Orthopedic · 79d
Cleared May 01, 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
K912640
Concept, Inc.
Orthopedic · 322d
Cleared Feb 28, 1992
CORTICAL BONE SCREW
K915448
Dow Corning Wright
Orthopedic · 81d
Cleared Feb 14, 1992
AAP BONE SCREW
K915316
Aap International, Ltd.
Orthopedic · 84d
Cleared Feb 13, 1992
BONE SCREW 3.5 MM
K915613
Acu Med, Inc.
Orthopedic · 59d
Cleared Feb 11, 1992
UNIVERSAL COMPRESION SCREW
K915124
Howmedica Corp.
Orthopedic · 90d
Cleared Jan 24, 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210
Depuy, Inc.
Orthopedic · 189d
Cleared Jan 13, 1992
OREGON FIXATION SCREW
K910976
Acu Med, Inc.
Orthopedic · 312d
Cleared Dec 19, 1991
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187
Techmedica, Inc.
Orthopedic · 31d
Cleared Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
K914004
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Nov 27, 1991
ACE CORTICAL BONE SCREW
K912598
Ace Medical Co.
Orthopedic · 170d
Cleared Nov 22, 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021
Instrument Makar, Inc.
Orthopedic · 199d
Cleared Nov 22, 1991
OSTEO BONE SCREWS
K913269
Fred C. Bryson
Orthopedic · 122d
Cleared Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
K913415
Aesculap, Inc.
Orthopedic · 90d
Cleared Oct 04, 1991
AMSET(TM) BONE SCREW
K911768
Advanced Med/Surg, Inc.
Orthopedic · 168d
Cleared Aug 23, 1991
HUENE FIXATION SCREW
K910193
Acu Med, Inc.
Orthopedic · 219d
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