Panels › Orthopedic › Product code KTT · Class 2
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation 888.3030
9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
Top companies in KTT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ebi, L.P. | 36 | 2 |
| Synthes | 33 | 1 |
| Stryker Corp. | 11 | 15 |
| Orthofix Srl | 11 | 12 |
| Howmedica Corp. | 22 | 0 |
| Howmedica Osteonics Corp. | 19 | 1 |
| Zimmer, Inc. | 10 | 9 |
| Smith & Nephew | 16 | 0 |
| Wrightmedicaltechnologyinc | 11 | 0 |
| Alliance Medical Corp. | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2005 | K052037 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. | KTT |
| Jul 27, 2005 | K051600 | SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM Synthes (Usa) | KTT |
| Jul 22, 2005 | K051180 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES Vanguard Medical Concepts, Inc. | KTT |
| Jul 19, 2005 | K051162 | GENEROS SB SMALL BONE DISTRACTION IMPLANT Orthonetx, Inc. | KTT |
| Jul 13, 2005 | K051049 | SYNTHES (USA) LOW-PROFILE WRIST FIXATOR Synthes (Usa) | KTT |
| Jun 29, 2005 | K051554 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES Alliance Medical Corp. | KTT |
| Jun 29, 2005 | K051017 | R-X-FIX EXTERNAL FIXATOR R-X-Fix | KTT |
| May 4, 2005 | K050849 | HA COATED LAG SCREW Smith & Nephew, Inc. | KTT |
| Mar 14, 2005 | K050457 | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM Merete Medical GmbH | KTT |
| Mar 4, 2005 | K050048 | HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. | KTT |
| Feb 11, 2005 | K043289 | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT Signal Medical Corp. | KTT |
| Feb 7, 2005 | K043174 | STEALTH FUSION SYSTEM, MODEL RR 1000 R&R Medical, Inc. | KTT |
| Jan 21, 2005 | K043113 | TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE DePuy Orthopaedics, Inc. | KTT |
| Jan 18, 2005 | K043039 | SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE Synthes (Usa) | KTT |
| Jan 7, 2005 | K033856 | 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN Peter Stevens, MD | KTT |
| Nov 17, 2004 | K042761 | WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES Zimmer, Inc. | KTT |
| Nov 16, 2004 | K042895 | SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES Synthes (Usa) | KTT |
| Oct 7, 2004 | K042436 | IIIZAROV PULLEY SYSTEM Smith & Nephew, Inc. | KTT |
| Oct 7, 2004 | K042358 | LOCON VLS DISTAL RADIUS PLATE SYSTEM Wrightmedicaltechnologyinc | KTT |
| Sep 24, 2004 | K042312 | JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE Smith & Nephew, Inc. | KTT |
| Sep 24, 2004 | K042019 | HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. | KTT |
| Sep 8, 2004 | K041911 | SYNTHES (USA) LCP CURVED PLATES Synthes (Usa) | KTT |
| Sep 8, 2004 | K041709 | NUMELOCK II SYSTEM Howmedica Osteonics Corp. | KTT |
| Sep 8, 2004 | K041706 | HOFFMANN II FOOT RING Howmedica Osteonics Corp. | KTT |
| Jul 6, 2004 | K040935 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Jul 1, 2004 | K041081 | FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES Hand Innovations, Inc. | KTT |
| Jul 1, 2004 | K041001 | OMEGA 2 SYSTEM Howmedica Osteonics Corp. | KTT |
| Apr 30, 2004 | K031687 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES Vanguard Medical Concepts, Inc. | KTT |
| Apr 29, 2004 | K040833 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Mar 23, 2004 | K040258 | SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE Synthes (Usa) | KTT |
| Mar 23, 2004 | K040064 | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR Newmedical Technology, Inc. | KTT |
| Mar 1, 2004 | K033995 | 3.5 MM LCP DISTAL HUMERUS SYSTEM Synthes (Usa) | KTT |
| Jan 20, 2004 | K033476 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. | KTT |
| Jan 13, 2004 | K033556 | SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM Synthes (Usa) | KTT |
| Dec 18, 2003 | K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM Plus Orthopedics | KTT |
| Dec 3, 2003 | K033635 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Nov 26, 2003 | K033411 | SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS Synthes (Usa) | KTT |
| Nov 5, 2003 | K033158 | SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES Synthes (Usa) | KTT |
| Nov 5, 2003 | K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS Hand Biomechanics Lab, Inc. | KTT |
| Oct 22, 2003 | K031875 | INTER-OS LIMB LENGTHENER Inter-Os Technologies | KTT |
| Sep 4, 2003 | K031919 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Aug 6, 2003 | K031401 | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) Disco-O-Tech Medical Technologies, Ltd., IL | KTT |
| Jul 30, 2003 | K032058 | MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES Alliance Medical Corp. | KTT |
| Jul 14, 2003 | K031724 | SYNTHES SMALL COBINATION CLAMP-MR SAFE Synthes (Usa) | KTT |
| Jul 14, 2003 | K031181 | EXTERNAL FIXATION SYSTEMS Smith & Nephew, Inc. | KTT |
| Jul 10, 2003 | K031093 | EBI XFIX OPTIROM KNEE FIXATOR Ebi, L.P. | KTT |
| Jun 25, 2003 | K031645 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Jun 24, 2003 | K031725 | SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM Synthes (Usa) | KTT |
| Jun 6, 2003 | K031573 | SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE Synthes (Usa) | KTT |
| Mar 6, 2003 | K030372 | MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM Ebi, L.P. | KTT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.