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)
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Top companies in HRS

DateFirm and productCodeLinked 510(k)
Feb 15, 2022Wright Medical Technology, Inc.
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Terminated
HRSK090692
Feb 9, 2022Wright Medical Technology, Inc.
The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The dr
Terminated
HRSK061808
Jan 4, 2022Smith & Nephew, Inc.
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Open, Classified
HRSK073375
Dec 3, 2021Wright Medical Technology Inc
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Open, Classified
HRSK061808
Dec 3, 2021Wright Medical Technology Inc
Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
Open, Classified
HRSK113014
Dec 3, 2021Wright Medical Technology, Inc.
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Open, Classified
HRSK141417
Nov 1, 2021Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Terminated
HRSK201918
Nov 1, 2021Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Terminated
HRSK201918
Nov 1, 2021Smith & Nephew, Inc.
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
Terminated
HRSK201918
Nov 1, 2021Smith & Nephew, Inc.
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Terminated
HRSK201918
Oct 25, 2021Smith & Nephew, Inc.
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Open, Classified
HRSK162078
Sep 3, 2021Flower Orthopedics Corporation
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Terminated
HRSK123562
Apr 30, 2021Wishbone Medical, Inc.
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
Terminated
HRSK180736
Mar 16, 2021K2M, Inc
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Terminated
HRSK111439
Mar 11, 2021Arthrex, Inc.
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Terminated
HRSK032187
Jan 21, 2021Biomet, Inc.
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bon
Terminated
HRSK173767
Aug 24, 2020Smith & Nephew, Inc.
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
Terminated
HRSK140814
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc
Terminated
HRSK133930
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the cal
Terminated
HRSK133930
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc
Terminated
HRSK133930
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca
Terminated
HRSK133930
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc
Terminated
HRSK133930
Aug 12, 2020Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca
Terminated
HRSK133930
Jul 21, 2020Synthes (USA) Products LLC
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, ra
Terminated
HRSK011335
Jun 24, 2020Arthrex, Inc.
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation fo
Terminated
HRSK141478
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and f
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and f
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the no
Terminated
HRSK083843
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures dur
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal
Terminated
HRSK083843
K173767
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures
Terminated
HRSK143697
May 14, 2020Biomet
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during t
Terminated
HRSK143697
Dec 16, 2019Nextremity Solutions
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Terminated
HRSK182201
Dec 16, 2019Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Terminated
HRSK103243
Dec 16, 2019Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Terminated
HRSK103243
Dec 16, 2019Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Terminated
HRSK103243
Dec 16, 2019Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Terminated
HRSK103243

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