ClearanceBrief
Panels › Orthopedic › Product code HRS · Class 2

Plate, Fixation, Bone

Regulation 888.3030

64510(k)s in 12 months (1,334 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)
Jun 7, 2018Orthofix, Inc
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Terminated
HRSK142135
Apr 16, 2018TriMed Inc.
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Pla
Terminated
HRSK043263
Mar 20, 2018Epic Extremity, LLC
Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
Terminated
HRSK153340
Mar 20, 2018Epic Extremity, LLC
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Terminated
HRSK153340
Dec 11, 2017Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R
Terminated
HRSK132886
Dec 11, 2017Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone
Terminated
HRSK132886
Nov 29, 2017Smith & Nephew, Inc.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragme
Terminated
HRSK140814
Oct 25, 2017Zimmer Biomet, Inc.
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Terminated
HRSK093474
K111663
Jul 13, 2017In2Bones, SAS
Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST01
Terminated
HRSK160995
Apr 14, 2017Smith & Nephew, Inc.
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Terminated
HRSK092015
Mar 9, 2017Smith & Nephew, Inc.
Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Terminated
HRSK062216
Feb 14, 2017Acumed LLC
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and
Terminated
HRSK122538
Jan 6, 2017In2Bones, SAS
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the dist
Terminated
HRSK160995
Jan 6, 2017In2Bones, SAS
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fracture
Terminated
HRSK160995
Jan 6, 2017In2Bones, SAS
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraartic
Terminated
HRSK160995
Nov 8, 2016Wright Medical Technology, Inc.
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Terminated
HRSK061808
Nov 8, 2016Wright Medical Technology, Inc.
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Terminated
HRSNone listed
Aug 29, 2016Trimed Inc
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conforma
Terminated
HRSK060041
Aug 11, 2016Synthes (USA) Products LLC
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices
Terminated
HRSK012114
K050110 +3
Jun 10, 2016Synthes (USA) Products LLC
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Terminated
HRSK070946
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Terminated
HRSK093880
K111663
May 10, 2016Integra LifeSciences Corp.
TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS
Terminated
HRSNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910
Terminated
HRSK150121
Mar 12, 2016Zimmer Manufacturing B.V.
Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800
Terminated
HRSK150121
Mar 12, 2016Zimmer Manufacturing B.V.
Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800
Terminated
HRSK150121
Mar 12, 2016Zimmer Manufacturing B.V.
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures du
Terminated
HRSNone listed
Jan 11, 2016Arthrex, Inc.
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titaniu
Terminated
HRSK031666
Dec 18, 2015Biomet, Inc.
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
Terminated
HRSK072083
K072832 +2
Dec 9, 2015Zimmer Biomet, Inc.
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated
Terminated
HRSK060710
Dec 4, 2015Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
Terminated
HRSK083032
Dec 4, 2015Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
Terminated
HRSK083032
Nov 6, 2015Synthes (USA) Products LLC
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Terminated
HRSK915818
Oct 30, 2015Synthes (USA) Products LLC
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of
Terminated
HRSK063049
Sep 28, 2015Synthes (USA) Products LLC
Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Varia
Terminated
HRSK120070
Sep 18, 2015OrthoPediatrics Corp
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
Terminated
HRSK111086
Sep 4, 2015Trilliant Surgical Ltd.
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small
Terminated
HRSK121452
Sep 1, 2015Wright Medical Technology, Inc.
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 1
Terminated
HRSK132594
Sep 1, 2015Wright Medical Technology, Inc.
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm
Terminated
HRSK132594
Aug 31, 2015Trilliant Surgical Ltd.
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part #
Terminated
HRSK121452
Jul 10, 2015Biomet, Inc.
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Terminated
HRSK111663
Jul 8, 2015Biomet, Inc.
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Terminated
HRSK093474
K111663
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
Terminated
HRSK132594
Apr 22, 2015Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
Terminated
HRSK132594

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