ClearanceBrief
Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

Company510(k)sRecalls
Zimmer Biomet, Inc.0295
DePuy Orthopaedics, Inc.9116
Zimmer GmbH2350
Stryker1237
Howmedica Osteonics390
OrthoPediatrics Corp.731
Ebi, L.P.131
Advanced Orthopaedic Solutions, Inc.1512
NuVasive Specialized Orthopedics189
Synthes (Usa)234
Decided510(k)Device and applicantCode
Dec 9, 2013K133289PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Ellipse Technologies, Inc.
HSB
Dec 5, 2013K133376AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
Tornier, Inc.
HSB
Oct 11, 2013K131677PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Ellipse Technologies, Inc.
HSB
Oct 10, 2013K131365T2 TIBIAL NAILING SYSTEM
Stryker Trauma AG
HSB
Oct 3, 2013K132774PICCOLO COMPOSITE NAILING SYSTEM
CarboFix Orthopedics , Ltd., IL
HSB
Sep 17, 2013K130595ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
Zimmer, Inc.
HSB
Sep 10, 2013K132005RETROGRADE FEMORAL NAIL
Advanced Orthopaedic Solutions, Inc.
HSB
Jul 15, 2013K130051611 ANKLE FUSION NAIL
Tornier S.A.S., FR
HSB
Jun 25, 2013K131005EBA2 FEMORAL NAILING SYSTEM
Citieffe S.R.L.
HSB
Jun 14, 2013K123810PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
CarboFix Orthopedics , Ltd., IL
HSB
May 24, 2013K123569ANTEGRADE FEMORAL NAIL
Advanced Orthopaedic Solutions, Inc.
HSB
May 3, 2013K130147ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
Small Bone Innovations, Inc.
HSB
Apr 16, 2013K122823SIGN PEDIATRIC FIN NAIL
Sign Fracture Care International
HSB
Mar 28, 2013K13062512MM AND 13MM TIBIAL NAILS
Advanced Orthopaedic Solutions, Inc.
HSB
Mar 25, 2013K123745SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
Biomecanica Industria E Comerico DE Productos Orto
HSB
Jan 23, 2013K123401GAMMA3 AND T2 RECON TARGETING DEVICES
Stryker Trauma AG
HSB
Oct 24, 2012K121312INTRAMEDULLARY NAIL SYSTEM
Weigao Orthopaedic Device Co., Ltd., CN
HSB
Oct 19, 2012K122170SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
Smith & Nephew, Inc.
HSB
Oct 19, 2012K113219ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Ellipse Technologies, Inc.
HSB
Oct 2, 2012K120148AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
Advanced Orthopaedic Solutions, Inc.
HSB
Sep 14, 2012K121575OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Ortho Solutions Limited
HSB
Aug 10, 2012K120715ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
Zimmer GmbH
HSB
Jul 6, 2012K120807SYNTHES MULTILOC HUMERAL NAILING SYSTEM
Synthes USA Products, LLC
HSB
May 21, 2012K120419DYNA LOCKING ANKLE NAIL
U&I Corp., KR
HSB
May 3, 2012K102577FORCE MEDICAL IM NAIL SYSTEM
Force Medical, Inc.
HSB
May 2, 2012K120978OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
Merete Medical GmbH, DE
HSB
Apr 2, 2012K112982ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
Small Bone Innovations, Inc.
HSB
Mar 28, 2012K113695ELLIPSE PRECICE TRAUMA NAIL SYSTEM
Ellipse Technologies, Inc.
HSB
Mar 15, 2012K113387CITIEFFE TITANIUM NAILING SYSTEM
Citieffe
HSB
Feb 29, 2012K113828DYNANAIL ANKLE ARTHRODESIS NAIL
MedShape, Inc.
HSB
Feb 15, 2012K113409S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
Howmedica Osteonics Corp.
HSB
Feb 8, 2012K120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
Synthes USA
HSB
Jan 26, 2012K111232GAP ENDO-EXO MEDULLARY SYSTEM
Pega Medical, Inc., CA
HSB
Dec 9, 2011K113303OSLEOBRIDGE IDSF SPACER CONECTOR
Merete Medical GmbH, DE
HSB
Nov 28, 2011K111891SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
Synthes (USA) Products, LLC
HSB
Nov 14, 2011K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
Vilex, Inc.
HSB
Aug 22, 2011K111352TALON DISTALFIX PROXIMAL FEMORAL NAIL
Orthopedic Designs North America, Inc.
HSB
Aug 19, 2011K111550SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
Sonoma Orthopedic Products, Inc.
HSB
Aug 8, 2011K112059T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
Stryker
HSB
Aug 3, 2011K101934DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
Medshape Solutions
HSB
Jul 12, 2011K101997ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Ellipse Technologies, Inc.
HSB
Jul 1, 2011K111025TRIGEN LOW PROFILE BONE SCREW
Smith & Nephew, Inc.
HSB
Jun 22, 2011K111444UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
DePuy Orthopaedics, Inc.
HSB
May 3, 2011K111056PICCOLO COMPOSITE NAILING SYSTEM
CarboFix Orthopedics , Ltd., IL
HSB
Mar 23, 2011K110552VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
Wrightmedicaltechnologyinc
HSB
Mar 4, 2011K110322OLECRA INTRAMEDULLARY FIXATION SYSTEM
Mylad Orthopedic Solutions
HSB
Mar 2, 2011K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
Synthes (Usa)
HSB
Jan 31, 2011K102369PICCOLO COMPOSITE NAILING SYSTEM
N.M.B. Medical Applications, Ltd., IL
HSB
Jan 19, 2011K103533ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
Advanced Orthopaedic Solutions, Inc.
HSB
Dec 22, 2010K102992T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
Howmedica Osteonics Corp.
HSB

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