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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
577–600 of 1311
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646
Synthes (Usa)
Orthopedic · 43d
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 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 Dec 10, 2004
PERIARTICULAR LOCKING PLATES, 2358 SERIES
K043227
Zimmer, Inc.
Orthopedic · 18d
Cleared Oct 29, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
K042598
Zimmer, Inc.
Orthopedic · 36d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355
Synthes (Usa)
Orthopedic · 57d
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 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 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
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777
Synthes (Usa)
Orthopedic · 84d
Cleared May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588
Synthes (Usa)
Orthopedic · 63d
Cleared Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593
Zimmer, Inc.
Orthopedic · 35d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519
Biomet, Inc.
Orthopedic · 28d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666
Arthrex, Inc.
Orthopedic · 173d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559
Synthes (Usa)
Orthopedic · 64d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187
Arthrex, Inc.
Orthopedic · 67d