Panels › Orthopedic › Product code MNH · Class 2
Orthosis, Spondylolisthesis Spinal Fixation
Regulation 888.3070
0510(k)s in 12 months (309 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in MNH
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 18 | 0 |
| Acromed Corp. | 14 | 0 |
| Depuyacromed | 13 | 0 |
| Sofamor Danek | 10 | 0 |
| Ebi, L.P. | 6 | 3 |
| Howmedica Osteonics | 9 | 0 |
| Advanced Spine Fixation Systems, Inc. | 8 | 0 |
| Stryker Spine | 4 | 3 |
| Ortho Tec, LLC | 6 | 0 |
| Solco Biomedical Co., Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2000 | K000641 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Dec 8, 2000 | K003490 | OPUS ROD FIXATION SYSTEM Howmedica Osteonics Corp. | MNH |
| Nov 24, 2000 | K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS Osteotech, Inc. | MNH |
| Nov 3, 2000 | K001044 | ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM Acme Spine, LLC | MNH |
| Oct 19, 2000 | K001668 | GLOBAL SPINAL FIXATION SYSTEM D.K.M. Co., Ltd. | MNH |
| Sep 27, 2000 | K002399 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Jul 11, 2000 | K001255 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Jun 22, 2000 | K001066 | CD HORIZON ECLIPSE Medtronic Sofamor Danek, Inc. | MNH |
| Jun 3, 2000 | K001627 | TRIFIX SPINAL FIXATION SYSTEM Endius, Inc. | MNH |
| May 23, 2000 | K001319 | XIA SPINE SYSTEM HOOKS Howmedica Osteonics Corp. | MNH |
| May 23, 2000 | K001024 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNH |
| May 10, 2000 | K991031 | COLORADO II SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Apr 14, 2000 | K993503 | HAIDER-UCR SPINAL SYSTEM International Advanced Medical Enterprises, Inc. | MNH |
| Apr 10, 2000 | K994288 | 5.0MM SPINAL SCREWS Ortho Tec, LLC | MNH |
| Mar 30, 2000 | K984360 | COLORADO II SPINAL SYSTEM Sofamor Danek USA,Inc. | MNH |
| Mar 10, 2000 | K000476 | MODIFICATION TO CD SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Mar 10, 2000 | K000453 | MODIFICATION TO CD SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MNH |
| Feb 28, 2000 | K994217 | BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | MNH |
| Feb 8, 2000 | K992739 | CLICK'X Synthes Spine | MNH |
| Feb 8, 2000 | K000094 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MNH |
| Feb 3, 2000 | K993810 | CD HORIZON SPINAL SYSTEM Danek Medical, Inc. | MNH |
| Feb 3, 2000 | K000020 | MODIFICATION TO ISOBAR SPINAL SYSTEM Encore Orthopedics, Inc. | MNH |
| Jan 13, 2000 | K993551 | SOCON SPINAL SYSTEM Aesculap, Inc. | MNH |
| Dec 17, 1999 | K993926 | OMNIAXIAL CONNECTOR Ortho Tec, LLC | MNH |
| Dec 6, 1999 | K993808 | SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 Interpore Cross Intl. | MNH |
| Sep 14, 1999 | K991036 | DANEK PLATE AND SCREW SYSTEM Sofamor Danek USA,Inc. | MNH |
| Aug 27, 1999 | K991055 | OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM Howmedica Osteonics Corp. | MNH |
| Jun 2, 1999 | K991552 | SYNTHES PEDIATRIC ROD SYSTEM Synthes (Usa) | MNH |
| May 28, 1999 | K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR Danek Medical, Inc. | MNH |
| May 27, 1999 | K990721 | ISOLOCK SPINAL SYSTEM Scien'Tx USA, Inc. | MNH |
| May 19, 1999 | K991460 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM Sofamor Danek | MNH |
| May 19, 1999 | K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES Sofamor Danek USA,Inc. | MNH |
| Mar 26, 1999 | K990657 | TRIFIX PEDICLE SPINAL SCREW ASSEMBLY Corin USA | MNH |
| Mar 22, 1999 | K990118 | ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. | MNH |
| Dec 18, 1998 | K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS Osteonics Corp. | MNH |
| Sep 25, 1998 | K983152 | OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS Osteonics Corp. | MNH |
| Aug 4, 1998 | K980761 | SYNTHES SPINE PEDIATRIC ROD SYSTEM Synthes Spine | MNH |
| Jun 30, 1998 | K981714 | TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM Acromed Corp. | MNH |
| May 29, 1998 | K981113 | PEDIATRIC PRC Acromed Corp. | MNH |
| May 20, 1998 | K980862 | TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| May 1, 1998 | K980852 | GII SPINAL FIXATION SYSTEM Karen E. Warden, M.E.B.E. | MNH |
| Apr 29, 1998 | K981274 | ACROMED TIMX PLATE BASED LOW BACK SYSTEM Acromed Corp. | MNH |
| Apr 14, 1998 | K980496 | WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER Wrightmedicaltechnologyinc | MNH |
| Apr 14, 1998 | K980447 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DePuy Orthopaedics, Inc. | MNH |
| Mar 18, 1998 | K973687 | SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNH |
| Mar 13, 1998 | K974749 | SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS Cross Medical Products, Inc. | MNH |
| Mar 10, 1998 | K974734 | AURORA TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
| Mar 5, 1998 | K973836 | SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM Cross Medical Products, Inc. | MNH |
| Feb 27, 1998 | K973425 | THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM Corin USA | MNH |
| Feb 4, 1998 | K974213 | AURORA TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | MNH |
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