HRS · Class II · 21 CFR 888.3030

FDA Product Code HRS: Plate, Fixation, Bone

FDA product code HRS covers bone fixation plates.

These implants stabilize fractures and osteotomies by bridging and compressing bone segments during healing. They are used across skeletal sites including the hand, wrist, foot, and ankle.

HRS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Synthes (Usa), Wrightmedicaltechnologyinc and Arthrex, Inc..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
1201–1224 of 1333
Cleared Feb 12, 1998
EPI-UNION PLATING SYSTEM
K974289
Howmedica, Inc.
Orthopedic · 90d
Cleared Jan 30, 1998
LACTOSORB PANELS
K974309
Biomet, Inc.
Orthopedic · 74d
Cleared Jan 21, 1998
CARPAL ENGAGING WRIST FUSION PLATE
K974030
Terray Corp.
Orthopedic · 90d
Cleared Jan 16, 1998
TIMESH SYSTEM
K974017
Sofamor Danek USA,Inc.
Orthopedic · 86d
Cleared Jan 12, 1998
ORBITAL RECONSTRUCTION PLATES
K973982
Howmedica, Inc.
Orthopedic · 84d
Cleared Dec 09, 1997
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438
Osteonics Corp.
Orthopedic · 90d
Cleared Nov 20, 1997
ORTHOPEDIC PLATE SYSTEM
K972219
Ferguson Medical
Orthopedic · 161d
Cleared Sep 25, 1997
OSTEO BOS SYSTEM IN STAINLESS STEEL
K973204
Osteonics Corp.
Orthopedic · 30d
Cleared Sep 11, 1997
ALTA PLATING SYSTEM
K972479
Howmedica Corp.
Orthopedic · 72d
Cleared Sep 10, 1997
BONE PLATE WITH CABLES
K972223
Pioneer Surgical Technology
Orthopedic · 89d
Cleared Sep 10, 1997
OSTEO BOS SYSTEM
K972323
Osteonics Corp.
Orthopedic · 82d
Cleared Aug 25, 1997
OSTEO ANATOMICAL BONE PLATES
K972196
Osteonics Corp.
Orthopedic · 76d
Cleared Aug 19, 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 11, 1997
LORENZ PECTUS SUPPORT BAR
K972420
Walter Lorenz Surgical, Inc.
Orthopedic · 45d
Cleared Jul 17, 1997
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719
Howmedica Leibinger, Inc.
Orthopedic · 441d
Cleared Jul 09, 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321
Osteonics Corp.
Orthopedic · 90d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES
K970258
Ferguson Medical
Orthopedic · 119d
Cleared May 08, 1997
CENTRE-DRIVE DRILL-FREE SCREW
K971297
KLS-Martin L.P.
Orthopedic · 30d
Cleared Apr 30, 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503
Depuy Ace Medical Co.
Orthopedic · 79d
Cleared Mar 25, 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325
Synthes (Usa)
Orthopedic · 214d
Cleared Feb 12, 1997
METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM
K963700
Metagen, LLC
Orthopedic · 149d
Cleared Feb 06, 1997
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K961498
Howmedica, Inc.
Orthopedic · 294d
Cleared Feb 06, 1997
LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
K963741
Howmedica Leibinger, Inc.
Orthopedic · 142d
Cleared Jan 16, 1997
KINAMED PROFIX SYSTEM
K964362
Kinamed, Inc.
Orthopedic · 76d