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..

1322
Total
1322
Cleared
116d
Avg days
1976
Since
1322 devices
1009–1032 of 1322
Cleared Apr 11, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607
Synthes (Usa)
Orthopedic · 32d
Cleared Mar 21, 2005
STRYKER LOCKED PLATING SYSTEM
K050512
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Mar 14, 2005
INTEGRA BONE FIXATION SYSTEM
K050492
Integra Lifesciences Corp.
Orthopedic · 14d
Cleared Mar 04, 2005
SYNTHES (USA) LCP MODULAR FOOT PLATES
K050110
Synthes (Usa)
Orthopedic · 45d
Cleared Jan 31, 2005
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
K050121
Zimmer, Inc.
Orthopedic · 12d
Cleared Jan 21, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
K043560
Zimmer, Inc.
Orthopedic · 25d
Cleared Jan 14, 2005
TRIMED OSTEOTOMY PLATE
K043263
TriMed, Inc.
Orthopedic · 51d
Cleared Dec 10, 2004
PERIARTICULAR LOCKING PLATES, 2358 SERIES
K043227
Zimmer, Inc.
Orthopedic · 18d
Cleared Nov 16, 2004
ORTHOFIX VOLAR DISTAL RADIAL PLATE
K042766
Orthofix, Inc.
Orthopedic · 42d
Cleared Oct 29, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
K042598
Zimmer, Inc.
Orthopedic · 36d
Cleared Oct 29, 2004
NCB PLATING SYSTEM
K042695
Zimmer GmbH
Orthopedic · 29d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355
Synthes (Usa)
Orthopedic · 57d
Cleared Oct 08, 2004
DORSAL INTRAMEDULLARY PLATE
K042437
Deo Volente Orthopaedics, LLC
Orthopedic · 30d
Cleared Oct 07, 2004
SYNTHES LOW PROFILE RECONSTRUCTION PLATES
K042377
Synthes (Usa)
Orthopedic · 36d
Cleared Sep 20, 2004
BONE FUSION PLATE SYSTEM
K042205
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Sep 16, 2004
EBI PERIARTICULAR PLATING SYSTEM
K042237
Ebi, L.P.
Orthopedic · 29d
Cleared Sep 08, 2004
CALCAMEA PLATE
K041786
New Deal, S.A.
Orthopedic · 69d
Cleared Sep 08, 2004
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
K041860
Synthes (Usa)
Orthopedic · 61d
Cleared Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
K041965
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 27, 2004
SURFIX KNEE OSTEOTOMY SYSTEM
K041601
Surfix Technologies
Orthopedic · 74d
Cleared Aug 16, 2004
EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
K033918
Ebi, L.P.
Orthopedic · 242d
Cleared Aug 16, 2004
KMI DISTAL VOLAR RADIUS PLATE SYSTEM
K041461
Kinetikos Medical, Inc.
Orthopedic · 75d
Cleared Jul 01, 2004
ARTHREX SMALL FRAGMENT PLATES AND SCREWS
K040907
Arthrex, Inc.
Orthopedic · 85d
Cleared Jul 01, 2004
RADIAL NAIL SYSTEM
K040938
Wrightmedicaltechnologyinc
Orthopedic · 80d