ClearanceBrief
Panels › Orthopedic › Product code HRS · Class 2

Plate, Fixation, Bone

Regulation 888.3030

62510(k)s in 12 months (1,332 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Get daily alerts for HRSSample briefCSV

Top companies in HRS

Company510(k)sRecalls
Synthes1048
Smith & Nephew3716
Biomet2128
Wrightmedicaltechnologyinc450
Zimmer GmbH3212
Wright Medical Technology Inc043
Arthrex, Inc.393
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Dec 21, 2022K222637TriMed Wrist Fixation System 3
TriMed, Inc.
HRS
Nov 22, 2022K221412ARIX Rib System
Jeil Medical Corporation, KR
HRS
Nov 15, 2022K221558ALPHALOK Plating System
Vilex, LLC
HRS
Nov 4, 2022K213108Humerus & Ulna System
Auxein Medical Private Limited, IN
HRS
Oct 27, 2022K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Hospital Equipment Manufacturing Company, IN
HRS
Oct 18, 2022K213123EVOS Wrist Spanning Plate
Smith & Nephew, Inc.
HRS
Oct 3, 2022K222267Arthrex 2.4 mm Volar Distal Radius Plate System
Arthrex, Inc.
HRS
Oct 3, 2022K213014Varixis Elbow System
Auxein Medical Private Limited, IN
HRS
Sep 30, 2022K222244Arthrex 3.5 mm Locking Compression Plates
Arthrex, Inc.
HRS
Sep 27, 2022K221360Medline UNITE® Medial Malleolus Peg Plate System
Medline Industries, LP
HRS
Sep 20, 2022K221809DePuy Synthes 3.5mm Intrapelvic Acetabular System
DePuy Synthes
HRS
Sep 2, 2022K213864Bonebridge Osteosynthesis Plating System
Bonebridge AG, CH
HRS
Aug 31, 2022K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
I.T.S. GmbH, AT
HRS
Aug 24, 2022K221920ARIX Small Fragment System
Jeil Medical Corporation, KR
HRS
Aug 19, 2022K222194Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.
HRS
Jul 8, 2022K221346Stryker VariAx 2 MIS Calcaneus
Stryker GmbH
HRS
Jul 1, 2022K221395Footmotion Plating System
Newclip Technics, FR
HRS
Jun 29, 2022K220937Arthrex Mini Fragment System
Arthrex, Inc.
HRS
Jun 17, 2022K221465Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
HRS
Jun 10, 2022K221362Omni Foot and Ankle Plating System
Exremity Medical, LLC
HRS
May 27, 2022K213698CoLink PCR Plating System
In2bones USA, LLC
HRS
May 20, 2022K212979CalcShift™ Displacement Calcaneal Osteotomy System
Nextremity Solutions, Inc.
HRS
May 18, 2022K220463Osteotomy Truss System (OTS)
4Web Medical, Inc.
HRS
May 17, 2022K212782SternaLock Sternal Closure System
Biomet Microfixation
HRS
May 2, 2022K213837Arthrx Fracture Plates
Arthrex, Inc.
HRS
May 2, 2022K212348ALPHALOK™ Plating System
Vilex, LLC
HRS
Apr 28, 2022K220244DVR® Crosslock Wrist Spanning Plate (131849181)
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
HRS
Apr 22, 2022K212608RibFix Blu Thoracic Fixation System
Biomet Microfixation
HRS
Apr 5, 2022K212601DRPx Locking Distal Radius Plate System
Orthopaedic Implant Company
HRS
Mar 21, 2022K220199AFFINITY Proximal Tibia System
Techfit Digital Surgery, Inc.
HRS
Mar 14, 2022K2113242.4mm Distal Radius System
Auxein Medical Private Limited, IN
HRS
Mar 11, 2022K213712Pectus Support Bar System
Biomet Microfixation
HRS
Mar 11, 2022K213005Apollo Ankle Fracture Plating System
Glw Medical, Inc.
HRS
Mar 11, 2022K201229Intai Anatomic Locking Plate and Screw System
Intai Technology Corporation, TW
HRS
Mar 4, 2022K211843PolyLock Plating System
Fusion Orthopedics
HRS
Mar 2, 2022K213567Medline UNITE Calcaneal Fracture Plating System
Medline Industries, LP
HRS
Feb 23, 2022K212378Arsenal Ankle Plating System
Trilliant Surgical
HRS
Feb 18, 2022K201510Traufix osteosynthesis, osteotomy, and arthrodesis devices
Fixier S.A. DE C.V., MX
HRS
Feb 16, 2022K220136Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.
HRS
Feb 11, 2022K212545FlexitSystem Knee osteotomy system
Neosteo, FR
HRS
Jan 27, 2022K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
Wishbone Medical, Inc.
HRS
Jan 26, 2022K213591ANTHEM® Fracture System
Globus Medical, Inc.
HRS
Jan 26, 2022K202914SternaFuse Fixation System
Fusion Innovations, LLC
HRS
Jan 19, 2022K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
Stryker GmbH
HRS
Jan 13, 2022K213895Distal Humerus Plating System
Skeletal Dynamics, Inc.
HRS
Jan 7, 2022K212841Pectus Blu Support Bar System
Biomet Micofixation
HRS
Jan 7, 2022K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking
Gpc Medical Limited, IN
HRS
Dec 16, 2021K202803Activmotion S DTO
Newclip Technics, FR
HRS
Dec 13, 2021K213069CoLink NeoFuse Plating System
In2bones USA, LLC
HRS
Nov 24, 2021K213214Xpert Wrist
Newclip Technics, FR
HRS

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.