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..

1319
Total
1319
Cleared
116d
Avg days
1976
Since
1319 devices
529–552 of 1319
Cleared Nov 19, 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538
Acumed, LLC
Orthopedic · 90d
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601
Aap Implantate AG
Orthopedic · 339d
Cleared Oct 31, 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602
Aap Implantate AG
Orthopedic · 331d
Cleared Oct 12, 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Oct 01, 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425
Wrightmedicaltechnologyinc
Orthopedic · 140d
Cleared Sep 06, 2012
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
K113648
Aap Implantate AG
Orthopedic · 269d
Cleared Aug 30, 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
K113652
Aap Implantate AG
Orthopedic · 262d
Cleared Jul 13, 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903
Acumed, LLC
Orthopedic · 109d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601
Synthes (Usa)
Orthopedic · 35d
Cleared Jun 18, 2012
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854
Synthes (Usa)
Orthopedic · 89d
Cleared Jun 12, 2012
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
K120772
Zimmer GmbH
Orthopedic · 90d
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689
Synthes USA Products, LLC
Orthopedic · 90d
Cleared May 10, 2012
EOS SMALL BONE FIXATION SYSTEM
K112794
TriMed, Inc.
Orthopedic · 227d
Cleared May 08, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
K120717
Synthes (Usa)
Orthopedic · 61d
Cleared May 03, 2012
ORTHOLOC 3DI HALLUX SYSTEM
K120359
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Apr 27, 2012
APTUS PROXIMAL HUMERUS SYSTEM
K120108
Medartis AG
Orthopedic · 105d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
K120667
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 02, 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Mar 21, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070
Synthes (Usa)
Orthopedic · 72d
Cleared Mar 12, 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663
DePuy Orthopaedics, Inc.
Orthopedic · 272d
Cleared Feb 29, 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Jan 31, 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Jan 27, 2012
NCB STRAIGHT NARROW SHAFT PLATES
K113718
Zimmer GmbH
Orthopedic · 39d