FDA Product Code
FDA Product Code KTT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 405 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052037 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-08-05 | Special | PDF ↗ |
| K051600 | SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM | Synthes (Usa) | 2005-07-27 | Traditional | PDF ↗ |
| K051180 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2005-07-22 | Traditional | PDF ↗ |
| K051162 | GENEROS SB SMALL BONE DISTRACTION IMPLANT | Orthonetx, Inc. | 2005-07-19 | Traditional | PDF ↗ |
| K051049 | SYNTHES (USA) LOW-PROFILE WRIST FIXATOR | Synthes (Usa) | 2005-07-13 | Traditional | PDF ↗ |
| K051554 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2005-06-29 | Special | PDF ↗ |
| K051017 | R-X-FIX EXTERNAL FIXATOR | R-X-Fix | 2005-06-29 | Traditional | PDF ↗ |
| K050849 | HA COATED LAG SCREW | Smith & Nephew, Inc. | 2005-05-04 | Special | PDF ↗ |
| K050457 | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM | Merete Medical GmbH | 2005-03-14 | Traditional | PDF ↗ |
| K050048 | HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-03-04 | Traditional | PDF ↗ |
| K043289 | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT | Signal Medical Corp. | 2005-02-11 | Traditional | PDF ↗ |
| K043174 | STEALTH FUSION SYSTEM, MODEL RR 1000 | R&R Medical, Inc. | 2005-02-07 | Traditional | PDF ↗ |
| K043113 | TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE | DePuy Orthopaedics, Inc. | 2005-01-21 | Abbreviated | PDF ↗ |
| K043039 | SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE | Synthes (Usa) | 2005-01-18 | Traditional | PDF ↗ |
| K033856 | 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN | Peter Stevens, MD | 2005-01-07 | Traditional | PDF ↗ |
| K042761 | WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES | Zimmer, Inc. | 2004-11-17 | Traditional | PDF ↗ |
| K042895 | SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES | Synthes (Usa) | 2004-11-16 | Special | PDF ↗ |
| K042436 | IIIZAROV PULLEY SYSTEM | Smith & Nephew, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K042358 | LOCON VLS DISTAL RADIUS PLATE SYSTEM | Wrightmedicaltechnologyinc | 2004-10-07 | Special | PDF ↗ |
| K042019 | HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2004-09-24 | Traditional | PDF ↗ |
| K042312 | JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE | Smith & Nephew, Inc. | 2004-09-24 | Special | PDF ↗ |
| K041709 | NUMELOCK II SYSTEM | Howmedica Osteonics Corp. | 2004-09-08 | Traditional | PDF ↗ |
| K041911 | SYNTHES (USA) LCP CURVED PLATES | Synthes (Usa) | 2004-09-08 | Traditional | PDF ↗ |
| K041706 | HOFFMANN II FOOT RING | Howmedica Osteonics Corp. | 2004-09-08 | Traditional | PDF ↗ |
| K040935 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2004-07-06 | Traditional | PDF ↗ |
| K041001 | OMEGA 2 SYSTEM | Howmedica Osteonics Corp. | 2004-07-01 | Traditional | PDF ↗ |
| K041081 | FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES | Hand Innovations, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K031687 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2004-04-30 | Traditional | PDF ↗ |
| K040833 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | Ebi, L.P. | 2004-04-29 | Special | PDF ↗ |
| K040258 | SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE | Synthes (Usa) | 2004-03-23 | Traditional | PDF ↗ |
| K040064 | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR | Newmedical Technology, Inc. | 2004-03-23 | Traditional | PDF ↗ |
| K033995 | 3.5 MM LCP DISTAL HUMERUS SYSTEM | Synthes (Usa) | 2004-03-01 | Traditional | PDF ↗ |
| K033476 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2004-01-20 | Special | PDF ↗ |
| K033556 | SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM | Synthes (Usa) | 2004-01-13 | Traditional | PDF ↗ |
| K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM | Plus Orthopedics | 2003-12-18 | Special | PDF ↗ |
| K033635 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | Ebi, L.P. | 2003-12-03 | Special | PDF ↗ |
| K033411 | SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS | Synthes (Usa) | 2003-11-26 | Special | PDF ↗ |
| K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS | Hand Biomechanics Lab, Inc. | 2003-11-05 | Traditional | PDF ↗ |
| K033158 | SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES | Synthes (Usa) | 2003-11-05 | Traditional | PDF ↗ |
| K031875 | INTER-OS LIMB LENGTHENER | Inter-Os Technologies | 2003-10-22 | Traditional | PDF ↗ |
| K031919 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2003-09-04 | Traditional | PDF ↗ |
| K031401 | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) | Disco-O-Tech Medical Technologies, Ltd. | 2003-08-06 | Traditional | PDF ↗ |
| K032058 | MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2003-07-30 | Special | PDF ↗ |
| K031181 | EXTERNAL FIXATION SYSTEMS | Smith & Nephew, Inc. | 2003-07-14 | Traditional | PDF ↗ |
| K031724 | SYNTHES SMALL COBINATION CLAMP-MR SAFE | Synthes (Usa) | 2003-07-14 | Traditional | PDF ↗ |
| K031093 | EBI XFIX OPTIROM KNEE FIXATOR | Ebi, L.P. | 2003-07-10 | Traditional | PDF ↗ |
| K031645 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2003-06-25 | Special | PDF ↗ |
| K031725 | SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM | Synthes (Usa) | 2003-06-24 | Traditional | PDF ↗ |
| K031573 | SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE | Synthes (Usa) | 2003-06-06 | Traditional | PDF ↗ |
| K030372 | MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM | Ebi, L.P. | 2003-03-06 | Traditional | PDF ↗ |
| K023714 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical Corp. | 2003-02-03 | Traditional | PDF ↗ |
| K023851 | PRECIMED HIP SCREW SYSTEM | Precimed, Inc. | 2003-01-28 | Traditional | PDF ↗ |
| K023941 | SYNTHES TOMOFIX OSTEOTOMY SYSTEM | Synthes (Usa) | 2003-01-23 | Traditional | PDF ↗ |
| K024248 | MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM | Ebi, L.P. | 2003-01-22 | Special | PDF ↗ |
| K024129 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | 2003-01-15 | Special | PDF ↗ |
| K023399 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2002-10-25 | Special | PDF ↗ |
| K023314 | MICROFIX | Fixano SA | 2002-10-18 | Traditional | PDF ↗ |
| K023324 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | 2002-10-18 | Special | PDF ↗ |
| K022771 | TWIN FIX | Fixano SA | 2002-09-23 | Traditional | PDF ↗ |
| K022423 | EXTERNAL FIXATION RING | Rigid FX Orthopedics, Incorporated | 2002-09-17 | Traditional | PDF ↗ |
| K021933 | TEMPFIX EXTERNAL FIXATION SYSTEM | DePuy Orthopaedics, Inc. | 2002-08-26 | Traditional | PDF ↗ |
| K022319 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2002-08-12 | Special | PDF ↗ |
| K012648 | REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2002-06-24 | Traditional | PDF ↗ |
| K012623 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical Corp. | 2002-06-24 | Traditional | PDF ↗ |
| K021695 | EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM | Ebi, L.P. | 2002-06-20 | Special | PDF ↗ |
| K020772 | OMEGA II SYSTEM | Howmedica Osteonics Corp. | 2002-06-05 | Traditional | PDF ↗ |
| K021312 | EBI DFS OPTIROM ELBOW FIXATOR | Ebi, L.P. | 2002-05-23 | Special | PDF ↗ |
| K021031 | EBI XFIX RAIL SYSTEM | Ebi, L.P. | 2002-05-16 | Traditional | PDF ↗ |
| K021091 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2002-05-03 | Special | PDF ↗ |
| K020311 | CLEARVIEW WRIST FIXATOR | Rigid FX Orthopedics, Incorporated | 2002-04-29 | Traditional | PDF ↗ |
| K020403 | MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR | Ebi, L.P. | 2002-03-08 | Special | PDF ↗ |
| K012294 | WRISTORE FIXATOR | Millennium Medical Technologies, Inc. | 2002-03-04 | Traditional | PDF ↗ |
| K014276 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | 2002-03-01 | Special | PDF ↗ |
| K020240 | SLIM GLIDING NAIL SYSTEM | Plus Orthopedics | 2002-02-22 | Special | PDF ↗ |
| K020141 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | Ebi, L.P. | 2002-02-05 | Special | PDF ↗ |
| K014194 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | Ebi, L.P. | 2002-01-17 | Special | PDF ↗ |
| K013540 | EBI XFIX ACCESS PELVIC FIXATOR | Ebi, L.P. | 2001-11-20 | Special | PDF ↗ |
| K013503 | MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR | DePuy Orthopaedics, Inc. | 2001-11-16 | Special | PDF ↗ |
| K013378 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2001-11-08 | Special | PDF ↗ |
| K012062 | PF2 | Fixano SA | 2001-09-27 | Traditional | PDF ↗ |
| K012078 | RADIOFIX | Fixano SA | 2001-09-27 | Traditional | PDF ↗ |
| K011603 | VHS PEDIATRIC HIP SCREW SYSTEM | Walter Abendschein, M.D. | 2001-08-15 | Traditional | PDF ↗ |
| K012024 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2001-07-25 | Special | PDF ↗ |
| K011711 | MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM | Ebi, L.P. | 2001-06-29 | Special | PDF ↗ |
| K011697 | EBI XFIX ACCESS PELVIC FIXATOR | Ebi, L.P. | 2001-06-27 | Special | PDF ↗ |
| K011034 | SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM | Synthes (Usa) | 2001-06-27 | Traditional | PDF ↗ |
| K010766 | SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE | Synthes (Usa) | 2001-06-12 | Traditional | PDF ↗ |
| K010518 | SYNTHES ANTEROLATERAL CALCANEAL PLATE | Synthes (Usa) | 2001-05-23 | Traditional | PDF ↗ |
| K010344 | ADJUSTABLE LARGE FIXATOR SYSTEM | Synthes (Usa) | 2001-05-03 | Traditional | PDF ↗ |
| K010437 | MODIFICATION TO EBI XFIX DFS RAIL SYSTEM | Ebi, L.P. | 2001-03-13 | Special | PDF ↗ |
| K003397 | COLLES C SERIES FRAME STERILE PACK | DePuy Orthopaedics, Inc. | 2001-01-29 | Traditional | PDF ↗ |
| K001358 | EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM | Ebi, L.P. | 2000-05-23 | Special | PDF ↗ |
| K000734 | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 | Pioneer Surgical Technology | 2000-05-05 | Traditional | PDF ↗ |
| K000682 | SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM | Synthes (Usa) | 2000-05-01 | Traditional | PDF ↗ |
| K000684 | SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM | Synthes (Usa) | 2000-04-28 | Traditional | PDF ↗ |
| K000319 | EBI XFIX DFS SYSTEM | Ebi, L.P. | 2000-02-25 | Special | PDF ↗ |
| K000083 | EBI XFIX DFS RAIL SYSTEM | Ebi, L.P. | 2000-02-03 | Special | PDF ↗ |
| K993873 | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD | Alphatec Mfg., Inc. | 2000-01-03 | Traditional | PDF ↗ |
| K993289 | SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM | Smith & Nephew, Inc. | 1999-12-20 | Abbreviated | PDF ↗ |
| K993886 | EBI XFIX VISION FIXATION SYSTEM | Ebi, L.P. | 1999-12-14 | Special | PDF ↗ |
Product code KTT · Class II · Orthopedic. Data: openFDA.