meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2014-06-26

Clearances · page 62 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133579 MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS Pontis Orthopaedics, LLC MBI Class II 2014-06-26
K140659 COROENT THORACOLUMBAR IMPLANTS Nu Vasive, Incorporated MAX Class II 2014-06-26
K133194 DIAMOND RATTLESNAKE SYSTEM Eminent Spine KWQ Class II 2014-06-26
K140053 KANGLI PEDICLE SCREW SPINAL SYSTEM Suzhou Kangli Orthopaedics Instrument Co., Ltd. MNH Class II 2014-06-26
K141002 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM Visionsense, Ltd. HRX Class II 2014-06-26
K141232 APTUS ULNA SHORTENING 2.5 Medartis AG HRS Class II 2014-06-23
K132697 ENCOMPASS 10/12 HIP STEM Ortho Development Corp. LPH Class II 2014-06-20
K141204 VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM Stryker Trauma AG HRS Class II 2014-06-20
K141121 AXSOS 3 TI LOCKING PLATE SYSTEM Stryker Trauma AG HRS Class II 2014-06-20
K140937 OSSEOFLEX SB Osseon, LLC NDN Class II 2014-06-19
K140678 COSMOLOCK PEDICLE SCREW SYSTEM Kalitec Direct, LLC MNH Class II 2014-06-19
K141029 TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM Tornier, Inc. PHX Class II 2014-06-18
K140073 U2 FEMORAL COMPONENT, CR, CEMENTED United Orthopedic Corp. JWH Class II 2014-06-16
K140759 BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL Medos International SARL MAX Class II 2014-06-13
K141383 ACUMED HAND FRACTURE SYSTEM Acumed, LLC HRS Class II 2014-06-13
K140075 U2 FEMORAL COMPONENT, CR, POROUS COATED United Orthopedic Corp. MBH Class II 2014-06-13
K140361 META-C CERVICAL PLATE Medacta International KWQ Class II 2014-06-12
K141259 GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK Depuy Mitek, A Johnson & Johnson Company MAI Class II 2014-06-10
K140675 EMERGE EXTERNAL FIXATION SYSTEM Emerge Medical, Inc. KTT Class II 2014-06-10
K140975 MASTERSL FEMORAL STEM Lima Corporate S.P.A. LZO Class II 2014-06-10
K133494 CHESAPEAKE SPINAL SYSTEM K2m, Inc. OVD Class II 2014-06-10
K140357 OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM Orthopaedic Implant Company HRS Class II 2014-06-09
K140564 BN LUMBAR CAGE SYSTEM Medyssey USA, Inc. MAX Class II 2014-06-05
K141006 RSP HUMERAL SOCKET INSERT Djo Global PHX Class II 2014-06-05
K140802 STERISPINE PS Safe Orthopaedics NKB Class II 2014-06-04
K141147 RANGE SPINAL SYSTEM K2m, Inc. NKB Class II 2014-06-03
K140891 BIOMET CANNULATED SCREW SYSTEM Biomet, Inc. HWC Class II 2014-06-03
K133349 SMR TT METAL BACK GLENOID Lima Corporate S.P.A. KWS Class II 2014-06-03
K140226 OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 Science For Biomaterials HRS Class II 2014-06-03
K140234 ASPIRON ACP SYSTEM U&I Corp. KWQ Class II 2014-06-02
K140358 COMPRESSYN STAPLE Dallen Medical, Inc. JDR Class II 2014-06-02
K133682 SCHOELLY ARTHROSCOPE Scholly Fiberoptic GmbH HRX Class II 2014-06-02
K133556 VIRAGE OCT SPINAL FIXATION SYSTEM Zimmer Spine, Inc. KWP Class II 2014-06-02
K140676 PROFEMUR TL CLASSIC LONG NECK HIP STEMS Microport Orthopedics, Inc. LZO Class II 2014-05-30
K140787 PLS (POSTERIOR LUMBAR SYSTEM) Sintea Plustek, LLC MNH Class II 2014-05-30
K140875 OPTOSSOL COMPRESSION DEVICE SYSTEM Genossis, LLC JDW Class II 2014-05-30
K133328 AERO-AL LUMBAR CAGE SYSTEM Stryker Corporation OVD Class II 2014-05-30
K132852 PEEK CAGE FOR THE VERTEBRAL SPINE Neoortho Produtos Ortopedicos S/A MAX Class II 2014-05-29
K140158 S.E.A.L. FRACTURE FUSION TUBE Dne, LLC KTT Class II 2014-05-29
K140555 JOURNEY II BCS CONSTRAINED INSERTS Smith & Nephew, Inc. JWH Class II 2014-05-29
K140822 DRIVE RAIL SYSTEM Devise Ortho, Inc. KTT Class II 2014-05-29
K140565 VARIAX 2 COMPRESSION PLATING SYSTEM Stryker Trauma AG HRS Class II 2014-05-29
K140509 BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE Biomet Manufacturing, LLC KRO Class II 2014-05-28
K140709 SKYHAWK INTERBODY FUSION SYSTEM Orthofix, Inc. MAX Class II 2014-05-27
K140423 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2014-05-27
K132788 MYSPINE PEDICLE SCREW PLACEMENT GUIDES Medacta International MNI Class II 2014-05-23
K140792 SALVATION 3DI PLATING SYSTEM Wrightmedicaltechnologyinc HRS Class II 2014-05-22
K140529 EVEREST SPINAL SYSTEM K2m, LLC NKB Class II 2014-05-22
K140027 ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER Materialise NV JWH Class II 2014-05-22
K132470 SOLUM IV BONE VOID FILLER Spinesmith Partners, Llp MQV Class II 2014-05-21
K140611 TRINICA ANTERIOR LUMBAR PLATE SYSTEM Zimmer Spine, Inc. KWQ Class II 2014-05-21
K133482 SILC FIXATION SYSTEM Globus Medical, Inc. OWI Class II 2014-05-21
K131609 DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM Xiamen Double Engine Medical Material Co., Ltd. HSB Class II 2014-05-21
K140576 Y WIRE 2 Safewire, LLC HXI Class I 2014-05-20
K132377 OSTEOSPAN MORPHEUS Biogennix, LLC MQV Class II 2014-05-20
K141023 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2014-05-20
K140948 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNH Class II 2014-05-20
K140925 ACUMED SUTURE ANCHOR SYSTEM Acumed, LLC MBI Class II 2014-05-20
K141043 CS2 MULTI-HOLE ACETABULAR SHELL Consensus Orthopedics, Inc. LPH Class II 2014-05-19
K140942 KLASSIC KNEE TIBIAL STEM EXTENSION Total Joint Orthopedics, Inc. JWH Class II 2014-05-16
K140741 SALVATION BEAMS AND BOLTS SYSTEM Wrightmedicaltechnologyinc HWC Class II 2014-05-15
K140952 CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW Wrightmedicaltechnologyinc HWC Class II 2014-05-15
K133662 SMITH & NEPHEW CANNULATED CAPTURED SCREW Smith & Nephew, Inc. HWC Class II 2014-05-15
K140604 MULTIFIX S KNOTLESS FIXATION SYSTEM ArthroCare Corporation MBI Class II 2014-05-14
K132653 NEOPLATE SPINE ANTERIOR FIXATION SYSTEM Neoortho Productos Orthopedicos S/A KWQ Class II 2014-05-14
K133153 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc. MNH Class II 2014-05-14
K140724 MSP METATARSAL SHORTENING SYSTEM Nextremity Solutions, Inc. HRS Class II 2014-05-14
K140408 SALVATION OSTEOPENIC SCREW Wrightmedicaltechnologyinc HWC Class II 2014-05-14
K140970 ONE-PIECE PEEK FUSION IMPLANT Mtp Solutions, LLC HWC Class II 2014-05-13
K140622 DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Biomet, Inc. HRS Class II 2014-05-13
K133378 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Zimmer, Inc. PHX Class II 2014-05-12
K140607 AAP LOQTEC(R) OLECRANON PLATE Aap Implantate AG HRS Class II 2014-05-08
K133200 STALIF C(R) Centinel Spine, Inc. OVE Class II 2014-05-08
K140238 EXCELLA III-D SPINAL DEFORMITY SYSTEM Innovasis, Inc. NKB Class II 2014-05-07
K133690 TRUE SPINAL FUSSION SYSTEM Innovative Surgical Designs MNH Class II 2014-05-07
K140814 EVOS MINI-FRAGMENT PLATING SYSTEM Smith & Nephew, Inc. HRS Class II 2014-05-07
K140904 RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 Encore Medical L.P. PHX Class II 2014-05-06
K140066 INFILL CERVICAL Pinnacle Spine Group, LLC ODP Class II 2014-05-05
K133616 MATRIXRIB FIXATION SYSTEM Synthes (USA) Products, LLC HRS Class II 2014-05-02
K133418 INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM Seaspine, Inc. MAX Class II 2014-05-01
K140216 ORTHOPEDIC FIXATION SYSTEMS Impact Medical, LLC HRS Class II 2014-05-01
K133514 XCAGE INTERBODY FUSION SYSTEM Ouroboros Medical MAX Class II 2014-05-01
K131920 STABILIZATION SCREW In2bones Sas HWC Class II 2014-05-01
K140229 GENERAL SPINAL SYSTEM Tianjin Walkman Biomaterial Co., Ltd. MNI Class II 2014-04-29
K133653 ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM Medtronic Sofamor Danek USA, Inc. ODP Class II 2014-04-28
K140742 RELIANCE ANTERIOR CERVICAL PLATE Reliance Medical Systems, LLC KWQ Class II 2014-04-25
K140617 PINIT SMALL BONE FUSION SYSTEM Arthrosurface, Inc. HRS Class II 2014-04-25
K140749 INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc HSN Class II 2014-04-25
K123607 OCTANE ELEVATE SPINAL IMPLANT SYSTEM Exactech, Inc. MAX Class II 2014-04-25
K140123 POLARIS SPINAL SYSTEM -TRANSLATION SCREW Ebi, LLC NKB Class II 2014-04-24
K140010 FORTRESS PEDICLE SCREW SYSTEM Spineology, Inc. NKB Class II 2014-04-23
K140303 ALAMO T Alliance Partners, LLC MAX Class II 2014-04-21
K140375 MASTERGRAFT PUTTY, MASTERGRAFT STRIP Medtronic Sofamor Danek USA, Inc. MQV Class II 2014-04-18
K133941 MITEK ARTHROSCOPES Medos International SARL HRX Class II 2014-04-18
K140474 JULIET OL Spineart MAX Class II 2014-04-18
K131612 ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES GS Medical Co., Ltd. MAX Class II 2014-04-18
K140625 ORTHOSORB LS Biomet, Inc. OVZ Class II 2014-04-18
K140715 ZIP MIS INTERSPINOUS FUSION SYSTEM Aurora Spine, Inc. PEK Class II 2014-04-17
K132724 ICONN ANSWER SUTURE ANCHOR Iconn Orthopedics, LLC MBI Class II 2014-04-17
K140769 VARIAX 2 SYSTEM Stryker Trauma AG HRS Class II 2014-04-17

17,115 clearances in the Orthopedic panel. Data: openFDA.