Panels › Orthopedic › Product code JDQ · Class 2
Cerclage, Fixation
Regulation 888.3010
1510(k)s in 12 months (130 all time)
0recalls in 12 months (15 all time)
11recalls that name a 510(k)
Top companies in JDQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Pioneer Surgical Technology | 13 | 1 |
| Howmedica Corp. | 8 | 0 |
| Synthes (Usa) | 8 | 0 |
| Alto Development Corp | 0 | 5 |
| Smith & Nephew, Inc. | 3 | 2 |
| A & E Medical Corporation | 4 | 0 |
| Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 4 | 0 |
| Acu Med, Inc. | 3 | 0 |
| Arthrex, Inc. | 3 | 0 |
| Biodynamic Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 2005 | K050041 | SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM Synthes (Usa) | JDQ |
| Jan 14, 2005 | K043252 | CABLING SYSTEM TROCHANTER HOOK Smith & Nephew, Inc. | JDQ |
| Mar 2, 2004 | K033816 | SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM Synthes (Usa) | JDQ |
| Feb 20, 2004 | K040199 | OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS Osseus, LLC | JDQ |
| Oct 21, 2003 | K030256 | ISO-ELASTIC CERCLAGE SYSTEM Kinamed, Inc. | JDQ |
| May 30, 2003 | K031508 | SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM Synthes (Usa) | JDQ |
| May 1, 2003 | K031162 | SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM Smith & Nephew, Inc. | JDQ |
| Mar 11, 2003 | K023564 | OSSE-LIGN Osseus, LLC | JDQ |
| Jun 27, 2001 | K010943 | SYNTHES STERNAL FIXATION SYSTEM Synthes (Usa) | JDQ |
| Mar 21, 2001 | K003951 | PECTOFIX STERNAL REPAIR WIRE Pectofix, Inc. | JDQ |
| Dec 13, 2000 | K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM Orthomatrix, Inc. | JDQ |
| Oct 6, 2000 | K002110 | SPL CRIMP SYSTEM Pioneer Surgical Technology | JDQ |
| Aug 31, 2000 | K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 Pioneer Surgical Technology | JDQ |
| May 11, 2000 | K000694 | PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) Pectofix, Inc. | JDQ |
| Feb 14, 2000 | K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 Whiteside Biomechanics, Inc. | JDQ |
| Nov 23, 1999 | K993286 | PIONEER SILICOAT STERNAL CABLE Pioneer Surgical Technology | JDQ |
| Nov 2, 1999 | K992891 | SYNTHES CERCLAGE POSITIONING PIN Synthes (Usa) | JDQ |
| Oct 27, 1999 | K992616 | SDB CERCLAGE SYSTEM Pioneer Surgical Technology | JDQ |
| Feb 24, 1999 | K984432 | DALL-MILES CABLE GRIP (A-GRIP) Howmedica Osteonics Corp. | JDQ |
| Dec 30, 1998 | K983976 | METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM Metagen, LLC | JDQ |
| Oct 19, 1998 | K982545 | BMP CABLE SYSTEM Biomet, Inc. | JDQ |
| May 22, 1998 | K980690 | CABLE SCREW WITH INTEGRAL CRIMP Pioneer Surgical Technology | JDQ |
| Dec 19, 1997 | K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM Spinal Concepts, Inc. | JDQ |
| Dec 19, 1997 | K974016 | CERCLAGE CABLE WITH HEX BUTTON Pioneer Surgical Technology | JDQ |
| Oct 27, 1997 | K973098 | COMPRESSION CERCLAGE GUNDOLF CCG-GF Plus Orthopedics | JDQ |
| Aug 11, 1997 | K972327 | METAGEN ACTIVELOCK CERCLAGE SYSTEM Pacific Materials and Interfaces | JDQ |
| Jul 16, 1997 | K971741 | DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE Howmedica Corp. | JDQ |
| Mar 13, 1997 | K970084 | LINK CERCLAGE WIRE SYSTEM Turnkey Intergration USA, Inc. | JDQ |
| Aug 14, 1996 | K962162 | DALL-MILES TROCHANTER CABLE SUPERGRIP Howmedica Corp. | JDQ |
| Aug 8, 1996 | K962132 | SILKON STAINLESS STEEL CABLE SYSTEM Osteonics Corp. | JDQ |
| Jun 27, 1996 | K961267 | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE Pioneer Surgical Technology | JDQ |
| Jun 24, 1996 | K961569 | DALL-MILES STAINLESS STEEL BEADED CABLE Howmedica Corp. | JDQ |
| May 22, 1996 | K961283 | DALL-MILES HOMOGENOUS VITALLIUM CABLE Howmedica Corp. | JDQ |
| May 3, 1996 | K960651 | CERCLAGE WIRE CRIMP BLOCK Acu-Med, Inc. | JDQ |
| Mar 8, 1996 | K953777 | SYNTHES WIRE MOUNT Synthes (Usa) | JDQ |
| Oct 12, 1995 | K953818 | DALL-MILES SUTURE/BEADED CABLE Howmedica Corp. | JDQ |
| Jul 13, 1995 | K951844 | BIOMECHANIC LOW-PROFILE CABLE SYSTEM Biomechanic, Inc. | JDQ |
| Mar 7, 1995 | K945294 | DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE Howmedica Corp. | JDQ |
| Mar 6, 1995 | K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK Intermedics Orthopedics | JDQ |
| Feb 17, 1995 | K944529 | CABLE-EASE PLATE AND CABLE SYSTEM Intermedics Orthopedics | JDQ |
| Feb 14, 1995 | K932024 | CCG CERCLAGE SYSTEM Encore Orthopedics, Inc. | JDQ |
| Jan 9, 1995 | K942300 | SILKON TITANIUM CABLE SYSTEM American Medical Electronics, Inc. | JDQ |
| Dec 21, 1994 | K940729 | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES Pioneer Surgical Technology | JDQ |
| Aug 1, 1994 | K934059 | DALL MILES SYSTEM GROOVED BUTTON Howmedica Corp. | JDQ |
| May 3, 1994 | K932687 | AME(R) UNIVERSIAL CABLE SYSTEM American Medical Electronics, Inc. | JDQ |
| Apr 19, 1994 | K941213 | SONGER CABLE SYSTEM Pioneer Surgical Technology | JDQ |
| Mar 9, 1994 | K935950 | FX-CABLELOK CABLE/PLATE SYSTEM Buckman Co., Inc. | JDQ |
| Mar 9, 1994 | K935646 | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM Biodynamic Technologies, Inc. | JDQ |
| Feb 25, 1994 | K934557 | CONTROL CABLE SYSTEM Depuy, Inc. | JDQ |
| Feb 23, 1994 | K934058 | DALL MILES SYSTEM MINICLEAT Howmedica Corp. | JDQ |
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