Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 38
- Latest Decision
- 2008-07-09
Clearances · page 92 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K080642 | COMPREHENSIVE REVERSE SHOULDER | Biomet, Inc. | PHX | Class II | 2008-07-09 |
| K081356 | OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM | Mylad Orthopedic Solutions, LLC | HSB | Class II | 2008-07-09 |
| K073341 | GENEX PUTTY | Biocomposites, Ltd. | MQV | Class II | 2008-07-09 |
| K080647 | ACCIN BIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | KWY | Class II | 2008-07-08 |
| K081598 | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE | Kfx Medical | MBI | Class II | 2008-07-03 |
| K081158 | ZODIC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | MNI | Class II | 2008-07-03 |
| K081567 | VERTEBRON SSP CERVICAL PLATING SYSTEM | Vertebron, Inc. | KWQ | Class II | 2008-07-03 |
| K081391 | VIP ANTERIOR CERVICAL PLATE SYSTEM | Globus Medical, Inc. | KWQ | Class II | 2008-07-03 |
| K081373 | EVOLVE EPS SYSTEM | Wrightmedicaltechnologyinc | HRS | Class II | 2008-07-03 |
| K080199 | SYMMETRIC TOTAL KNEE SYSTEM | Signal Medical Corporation | JWH | Class II | 2008-07-03 |
| K073500 | ACTIVE ANTERIOR CERVICAL PLATE SYSTEM | Sanacor | KWQ | Class II | 2008-07-03 |
| K071074 | MYKRES SPINAL SYSTEM | Showa Ika Kohgyo Co., Ltd. | MNI | Class II | 2008-07-02 |
| K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | MNI | Class II | 2008-07-02 |
| K071668 | ORTHOBIOM SPINAL SYSTEM | Paradigm Spine | MNI | Class II | 2008-07-02 |
| K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM | Biomet Spine | OVD | Class II | 2008-07-02 |
| K072678 | LAGUNA SIZE 8 PEDICLE SCREW | Allez Spine, LLC | NKB | Class II | 2008-07-02 |
| K081383 | RELIANCE VBS SYSTEM | Reliance Medical Systems, LLC | MQP | Class II | 2008-07-02 |
| K073303 | NORIAN DRILLABLE | Synthes (Usa) | OIS | Class II | 2008-07-02 |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | MQP | Class II | 2008-07-02 |
| K080991 | DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM | DePuy Orthopaedics, Inc. | KWA | Class III | 2008-07-02 |
| K080822 | VU APOD INTERVERTABRAL BODY FUSION DEVICE | Theken Spine, LLC | OVD | Class II | 2008-07-02 |
| K080974 | TLS FIXATION SYSTEM | Fournitures Hospitalieres Industrie | HWC | Class II | 2008-07-01 |
| K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS | Synthes (Usa) | JDQ | Class II | 2008-07-01 |
| K081620 | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM | DePuy Orthopaedics, Inc. | KWS | Class II | 2008-06-30 |
| K080537 | L-VARLOCK | Kiscomedica S.A. | MAX | Class II | 2008-06-30 |
| K081564 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION | Creaspine | MQP | Class II | 2008-06-30 |
| K081243 | BIOMET PHOENIX ANKLE NAIL SYSTEM | Biomet Trauma | HSB | Class II | 2008-06-27 |
| K081041 | GPS, G SURGICAL PEDICLE SYSTEM | G Surgical Co., Ltd. | MNH | Class II | 2008-06-27 |
| K080828 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | MNH | Class II | 2008-06-27 |
| K080617 | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | HRX | Class II | 2008-06-27 |
| K081395 | SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM | Biomet Spine | OVD | Class II | 2008-06-25 |
| K073556 | MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS | Medxpert GmbH | HRS | Class II | 2008-06-24 |
| K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM | Bioretec, Ltd. | HTY | Class II | 2008-06-24 |
| K072326 | OSTAPEK VBR SYSTEM | Co-Ligne AG | MQP | Class II | 2008-06-24 |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | HSX | Class II | 2008-06-20 |
| K073316 | CERAMENT BONE VOID FILLER, MODEL A0210 | Bonesupport AB | MQV | Class II | 2008-06-20 |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | Biocomposites, Ltd. | HWC | Class II | 2008-06-20 |
| K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN | Bioretec, Ltd. | HWC | Class II | 2008-06-18 |
| K081106 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 | Smith & Nephew, Inc. | HRS | Class II | 2008-06-18 |
| K081414 | MODIFICATION TO CORAL SPINAL SYSTEM | Theken Spine, LLC | NKB | Class II | 2008-06-17 |
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | KWN | Class II | 2008-06-17 |
| K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | Titan Spine, LLC | MAX | Class II | 2008-06-17 |
| K081439 | VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE | Orthovita, Inc. | MQV | Class II | 2008-06-17 |
| K080528 | E-POLY TIBIAL BEARINGS | Biomet Orthopedics, Inc. | JWH | Class II | 2008-06-17 |
| K062254 | AXIS FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | NKB | Class II | 2008-06-16 |
| K081381 | RANGE SPINAL SYSTEM, LARGE DENALI SCREWS | K2m, Inc. | MNH | Class II | 2008-06-13 |
| K080447 | SURGICRAFT SCREW FIXATION SYSTEM | Surgicraft , Ltd. | MBI | Class II | 2008-06-13 |
| K081297 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | KWP | Class II | 2008-06-11 |
| K080088 | BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS | Biomet Manufacturing, Inc. | HWC | Class II | 2008-06-11 |
| K080330 | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER | Biomet, Inc. | KRO | Class II | 2008-06-11 |
| K080673 | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE | Vertebral Technologies, Inc. | MAX | Class II | 2008-06-10 |
| K081152 | T2 FEMORAL NAIL | Howmedica Osteonics Corp. | HSB | Class II | 2008-06-10 |
| K081332 | ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM | Signus Medizintechnik GmbH | MQP | Class II | 2008-06-10 |
| K080773 | THOR ANTERIOR PLATING SYSTEM | Stryker Spine | KWQ | Class II | 2008-06-09 |
| K072852 | SL-PLUS STANDARD AND LATERAL HIP STEMS | Smith & Nephew, Inc. | LZO | Class II | 2008-06-09 |
| K080706 | CONNEXX LOCKING TIBIA NAIL | I.T.S. Implantat-Technologie-Systeme GmbH | JDS | Class II | 2008-06-09 |
| K081458 | PROVEN STEM EXTENDER | Stelkast Company | JWH | Class II | 2008-06-06 |
| K072198 | X-VOID, SPIDER | Sintea Biotech, Inc. | HRX | Class II | 2008-06-06 |
| K081296 | PREFERENCE PEDICLE SCREW SYSTEM | Us Spine | MNH | Class II | 2008-06-06 |
| K073109 | STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM | Surgicraft , Ltd. | OVD | Class II | 2008-06-04 |
| K080876 | DVX SPINE SYSTEM | Bk Meditech, Co., Ltd. | MNH | Class II | 2008-06-04 |
| K073708 | FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM | Precision Surgery , Ltd. | KWQ | Class II | 2008-06-03 |
| K081044 | REJUVENATE MODULAR HIP SYSTEM | Howmedica Osteonics Corp. | MEH | Class II | 2008-06-03 |
| K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | Orthopediatrics, LLC | HTY | Class II | 2008-06-03 |
| K071916 | METHA HIP SYSTEM | Aesculap Implant Systems, Inc. | MEH | Class II | 2008-06-02 |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | JDI | Class II | 2008-06-02 |
| K081252 | EXPEDIUM 4.5MM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2008-05-30 |
| K080588 | SCIENT'X TRIBECA VBR | Scient'X USA, Inc. | MAX | Class II | 2008-05-30 |
| K081194 | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | Rsb Spine, LLC | OVE | Class II | 2008-05-29 |
| K080728 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | MQP | Class II | 2008-05-29 |
| K080860 | CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM | Creaspine | MQP | Class II | 2008-05-29 |
| K081278 | OMEGA 3 TROCHANTERIC STABILIZING PLATE | Howmedica Osteonics Corp. | KTT | Class II | 2008-05-29 |
| K081195 | REVERE UNIPLANAR SCREWS | Globus Medical, Inc. | NKB | Class II | 2008-05-28 |
| K080522 | SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES | Synthes (Usa) | HRS | Class II | 2008-05-23 |
| K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] | Omni Life Science, Inc. | MBH | Class II | 2008-05-23 |
| K080020 | ARCOFIX | Synthes Spine Co.Lp | KWQ | Class II | 2008-05-23 |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | Tecres S.P.A. | KWL | Class II | 2008-05-22 |
| K062274 | SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 | Tecres S.P.A. | JWH | Class II | 2008-05-22 |
| K080767 | CONQUEST SPINAL SYSTEM | Life Spine | MNI | Class II | 2008-05-21 |
| K080699 | NOVEL SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | MQP | Class II | 2008-05-21 |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | Mako Surgical Corp. | KRR | Class II | 2008-05-16 |
| K073285 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | Medtronic Sofamor Danek USA, Inc. | OVE | Class II | 2008-05-15 |
| K081090 | PROFEMUR LX 5/8 COATED HIP STEM | Wrightmedicaltechnologyinc | KWA | Class III | 2008-05-15 |
| K072817 | ECHELON TITANIUM HIP SYSTEM | Smith & Nephew, Inc. | LPH | Class II | 2008-05-15 |
| K073562 | MODIFICATION TO VIPER SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2008-05-15 |
| K080411 | PLATEAU SPACER SYSTEM | Life Spine | MAX | Class II | 2008-05-15 |
| K081155 | SMARTSET MV BONE CEMENT | DePuy Orthopaedics, Inc. | LOD | Class II | 2008-05-14 |
| K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | MBB | Class II | 2008-05-14 |
| K073312 | OSTEOTRANS-OT SCREW | Takiron Co., Ltd. | HWC | Class II | 2008-05-13 |
| K073311 | OSTEOTRANS-OT PIN | Takiron Co., Ltd. | HTY | Class II | 2008-05-13 |
| K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM | Pioneer Surgical Technology | MAX | Class II | 2008-05-13 |
| K080314 | SPINAL USA INTERBODY FUSION DEVICE | Spinal USA | MAX | Class II | 2008-05-13 |
| K080936 | CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS | Conformis, Inc. | JWH | Class II | 2008-05-12 |
| K081228 | CAPSURE PS (R) SPINE SYSTEM | Spine Wave, Inc. | MNI | Class II | 2008-05-12 |
| K080584 | METHA SHORT STEM HIP SYSTEM | Aesculap Implant System, Inc. | MEH | Class II | 2008-05-09 |
| K080401 | SHELL CAGE, WAVE CAGE, LOOP CAGE | Advanced Medical Technologies AG | MAX | Class II | 2008-05-09 |
| K080313 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | NKB | Class II | 2008-05-08 |
| K080625 | SMITH & NEPHEW MIS HIP STEM WITH STIKTITE | Smith & Nephew, Inc. | LPH | Class II | 2008-05-08 |
| K080569 | LDR SPINE ROI-T IMPLANT | Ldr Spine USA | MQP | Class II | 2008-05-07 |
| K080590 | AOS PROXIMAL HUMERAL PLATE | Advanced Orthopaedic Solutions, Inc. | KTW | Class II | 2008-05-06 |
17,115 clearances in the Orthopedic panel. Data: openFDA.