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

Company510(k)sRecalls
Synthes1048
Smith & Nephew3716
Biomet2128
Wrightmedicaltechnologyinc450
Zimmer GmbH3212
Arthrex, Inc.403
Wright Medical Technology Inc043
DePuy Orthopaedics, Inc.1814
Medartis AG320
TriMed, Inc.256
Decided510(k)Device and applicantCode
Oct 25, 2007K072083SMALL FRAGMENT LOCKING PLATING SYSTEM
DePuy Orthopaedics, Inc.
HRS
Oct 5, 2007K070592SMALL BONE WEDGE
Wrightmedicaltechnologyinc
HRS
Sep 17, 2007K071798MONDEAL DISTAL RADIUS SYSTEM
Mondeal Medical Systems GmbH
HRS
Sep 17, 2007K071797MONDEAL HAND CONTOUR SYSTEM
Mondeal Medical Systems GmbH
HRS
Sep 6, 2007K071577BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
Biomet Microfixation, Inc.
HRS
Aug 21, 2007K072175TITANIUM HIP TOOL LOCKING PLATE
Orthopedic Sciences, Inc.
HRS
Aug 8, 2007K071563PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
Smith & Nephew, Inc.
HRS
Aug 7, 2007K071549SBI RHEAD PLATING SYSTEM
Small Bone Innovations, Inc.
HRS
Jul 30, 2007K071105OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
Osteomed LP
HRS
Jul 27, 2007K063275DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)
Terray Corp., CA
HRS
Jul 26, 2007K071325BIOMET VARIABLE LOCKING PLATE SYSTEM
Biomet Trauma
HRS
Jul 18, 2007K071715ACUMED CONGRUENT BONE PLATE SYSTEM
Acumed, LLC
HRS
Jul 9, 2007K071264SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
Synthes (Usa)
HRS
Jun 22, 2007K071184SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
Synthes (Usa)
HRS
Jun 6, 2007K070946SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
Synthes (Usa)
HRS
May 30, 2007K070793SBI DISTAL RADIUS VOLAR PLATING SYSTEM
Small Bone Innovations, Inc.
HRS
May 7, 2007K070823GROWTH CONTROL PLATING SYSTEM
Biomet Trauma
HRS
Mar 29, 2007K070447NEWDEAL COMPRESSION PLATE
Newdeal Sas
HRS
Mar 28, 2007K070208SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
Synthes (Usa)
HRS
Mar 26, 2007K070169KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
KLS Martin L.P.
HRS
Mar 15, 2007K063875STRYKER FOOT PLATING SYSTEM
Howmedica Osteonics Corp.
HRS
Mar 6, 2007K063726PLC SUTURE ANCHOR
Smith & Nephew Inc., Endoscopy Div.
HRS
Mar 2, 2007K070170DALL-MILES SYSTEM
Stryker Orthopaedics
HRS
Feb 8, 2007K070241MODIFICATION TO LAPIDUS PLATE
New Deal, S.A.
HRS
Feb 8, 2007K070160MODIFICATION TO TTC PLATES
New Deal, S.A.
HRS
Feb 8, 2007K063820LISFRANC PLATE
New Deal, S.A.
HRS
Feb 7, 2007K063831BASAL DORSAL PLATES
Newdeal Sas
HRS
Feb 2, 2007K063672FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
I.T.S. Implantat-Technologie-Systeme GmbH
HRS
Jan 23, 2007K063410INION CPS/OTPS FREEDOMPLATE
Inion , Ltd., FI
HRS
Jan 4, 2007K063709TS-BONE HIP TOOL
Orthopedic Sciences, Inc.
HRS
Dec 27, 2006K063009FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
Praesidia S.R.L.
HRS
Dec 22, 2006K063166I.T.S. PELVIC RECONSTRUCTION SYSTEM
I.T.S. Implantat-Technologie-Systeme GmbH
HRS
Dec 22, 2006K063095HUMERUS LOCKING PLATING SYSTEM
Newclip Technics
HRS
Dec 18, 2006K063506LORENZ STERNAL CLOSURE SYSTEM
Walter Lorenz Surgical, Inc.
HRS
Dec 18, 2006K063049SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
Synthes (Usa)
HRS
Dec 14, 2006K063020INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM
Intai Technology, Inc.
HRS
Dec 7, 2006K063460ACUMED CONGRUENT BONE PLATE SYSTEM
Acumed, LLC
HRS
Nov 22, 2006K063303UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
Zimmer, Inc.
HRS
Nov 1, 2006K063033MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
Orthopedic Sciences, Inc.
HRS
Oct 25, 2006K062498PROFYLE SYSTEM
Howmedica Osteonics Corp.
HRS
Oct 20, 2006K062903SBI CARPAL FUSION PLATE
Small Bone Innovations, Inc.
HRS
Oct 19, 2006K062564SYNTHES LCP DISTAL FEMUR PLATES
Synthes (Usa)
HRS
Oct 19, 2006K062494EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
Ebi, L.P.
HRS
Sep 29, 2006K062747ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
Arthrex, Inc.
HRS
Sep 15, 2006K062216PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
Smith & Nephew, Inc.
HRS
Sep 11, 2006K061973SYNTHES 3.5MM SPRING PLATE
Synthes (Usa)
HRS
Sep 8, 2006K061940SYNTHES LCP ANKLE ARTHRODESIS PLATES
Synthes (Usa)
HRS
Sep 7, 2006K051165KLS MARTIN STERNAL TALON
KLS-Martin L.P.
HRS
Aug 28, 2006K061917DISTAL RADIUS LOCKING PLATING SYSTEM
Newclip Technics
HRS
Aug 17, 2006K061808DARCO LOCKING BONE PLATE SYSTEM
Darco International, Inc.
HRS

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