FDA Product Code
FDA Product Code MNH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 309 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000641 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-12-22 | Traditional | PDF ↗ |
| K003490 | OPUS ROD FIXATION SYSTEM | Howmedica Osteonics Corp. | 2000-12-08 | Special | PDF ↗ |
| K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS | Osteotech, Inc. | 2000-11-24 | Special | PDF ↗ |
| K001044 | ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM | Acme Spine, LLC | 2000-11-03 | Traditional | PDF ↗ |
| K001668 | GLOBAL SPINAL FIXATION SYSTEM | D.K.M. Co., Ltd. | 2000-10-19 | Traditional | PDF ↗ |
| K002399 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-09-27 | Special | PDF ↗ |
| K001255 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-07-11 | Traditional | PDF ↗ |
| K001066 | CD HORIZON ECLIPSE | Medtronic Sofamor Danek, Inc. | 2000-06-22 | Traditional | PDF ↗ |
| K001627 | TRIFIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2000-06-03 | Special | PDF ↗ |
| K001024 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | 2000-05-23 | Traditional | PDF ↗ |
| K001319 | XIA SPINE SYSTEM HOOKS | Howmedica Osteonics Corp. | 2000-05-23 | Special | PDF ↗ |
| K991031 | COLORADO II SPINAL SYSTEM | Sofamor Danek USA,Inc. | 2000-05-10 | Traditional | PDF ↗ |
| K993503 | HAIDER-UCR SPINAL SYSTEM | International Advanced Medical Enterprises, Inc. | 2000-04-14 | Traditional | PDF ↗ |
| K994288 | 5.0MM SPINAL SCREWS | Ortho Tec, LLC | 2000-04-10 | Special | PDF ↗ |
| K984360 | COLORADO II SPINAL SYSTEM | Sofamor Danek USA,Inc. | 2000-03-30 | Traditional | PDF ↗ |
| K000476 | MODIFICATION TO CD SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-03-10 | Special | PDF ↗ |
| K000453 | MODIFICATION TO CD SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-03-10 | Special | PDF ↗ |
| K994217 | BLACKSTONE SPINAL FIXATION SYSTEM | Blackstone Medical, Inc. | 2000-02-28 | Traditional | PDF ↗ |
| K992739 | CLICK'X | Synthes Spine | 2000-02-08 | Traditional | PDF ↗ |
| K000094 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2000-02-08 | Special | PDF ↗ |
| K000020 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | 2000-02-03 | Special | PDF ↗ |
| K993810 | CD HORIZON SPINAL SYSTEM | Danek Medical, Inc. | 2000-02-03 | Special | PDF ↗ |
| K993551 | SOCON SPINAL SYSTEM | Aesculap, Inc. | 2000-01-13 | Traditional | PDF ↗ |
| K993926 | OMNIAXIAL CONNECTOR | Ortho Tec, LLC | 1999-12-17 | Special | PDF ↗ |
| 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. | 1999-12-06 | Special | PDF ↗ |
| K991036 | DANEK PLATE AND SCREW SYSTEM | Sofamor Danek USA,Inc. | 1999-09-14 | Traditional | PDF ↗ |
| K991055 | OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM | Howmedica Osteonics Corp. | 1999-08-27 | Traditional | PDF ↗ |
| K991552 | SYNTHES PEDIATRIC ROD SYSTEM | Synthes (Usa) | 1999-06-02 | Special | PDF ↗ |
| K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | Danek Medical, Inc. | 1999-05-28 | Special | PDF ↗ |
| K990721 | ISOLOCK SPINAL SYSTEM | Scien'Tx USA, Inc. | 1999-05-27 | Traditional | PDF ↗ |
| K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | Sofamor Danek USA,Inc. | 1999-05-19 | Special | PDF ↗ |
| K991460 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | Sofamor Danek | 1999-05-19 | Special | PDF ↗ |
| K990657 | TRIFIX PEDICLE SPINAL SCREW ASSEMBLY | Corin USA | 1999-03-26 | Special | PDF ↗ |
| K990118 | ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | 1999-03-22 | Traditional | PDF ↗ |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | Osteonics Corp. | 1998-12-18 | Special | PDF ↗ |
| K983152 | OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS | Osteonics Corp. | 1998-09-25 | Special | PDF ↗ |
| K980761 | SYNTHES SPINE PEDIATRIC ROD SYSTEM | Synthes Spine | 1998-08-04 | Traditional | PDF ↗ |
| K981714 | TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM | Acromed Corp. | 1998-06-30 | Traditional | PDF ↗ |
| K981113 | PEDIATRIC PRC | Acromed Corp. | 1998-05-29 | Traditional | PDF ↗ |
| K980862 | TITANIUM SPINAL ROD SYSTEM | United States Surgical, A Division of Tyco Healthc | 1998-05-20 | Traditional | PDF ↗ |
| K980852 | GII SPINAL FIXATION SYSTEM | Karen E. Warden, M.E.B.E. | 1998-05-01 | Traditional | PDF ↗ |
| K981274 | ACROMED TIMX PLATE BASED LOW BACK SYSTEM | Acromed Corp. | 1998-04-29 | Special | PDF ↗ |
| K980496 | WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER | Wrightmedicaltechnologyinc | 1998-04-14 | Traditional | PDF ↗ |
| K980447 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | DePuy Orthopaedics, Inc. | 1998-04-14 | Traditional | PDF ↗ |
| K973687 | SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 1998-03-18 | Traditional | PDF ↗ |
| K974749 | SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS | Cross Medical Products, Inc. | 1998-03-13 | Traditional | PDF ↗ |
| K974734 | AURORA TITANIUM SPINAL ROD SYSTEM | United States Surgical, A Division of Tyco Healthc | 1998-03-10 | Traditional | PDF ↗ |
| K973836 | SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM | Cross Medical Products, Inc. | 1998-03-05 | Traditional | PDF ↗ |
| K973425 | THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM | Corin USA | 1998-02-27 | Traditional | PDF ↗ |
| K974213 | AURORA TITANIUM SPINAL ROD SYSTEM | United States Surgical, A Division of Tyco Healthc | 1998-02-04 | Traditional | PDF ↗ |
| K973683 | OMEGA 21 SYSTEM | Ebi Electro Biology | 1997-12-24 | Traditional | PDF ↗ |
| K972568 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM | Depuy, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K971970 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1997-08-20 | Traditional | PDF ↗ |
| K970285 | AESUCLAP SOCON SPINAL SYSTEM | Aesculap, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K970950 | EASY ROD | Acromed Corp. | 1997-06-03 | Traditional | PDF ↗ |
| K965102 | ACROMED PEDICLE SCREW | Acromed Corp. | 1997-05-08 | Traditional | PDF ↗ |
| K964533 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1997-04-09 | Traditional | PDF ↗ |
| K965046 | ISOLA TWISTER CONNECTOR | Acromed Corp. | 1997-03-14 | Traditional | PDF ↗ |
| K963045 | SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM | Synthes (Usa) | 1997-02-13 | Traditional | PDF ↗ |
| K964544 | OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY | Osteonics Corp. | 1997-02-11 | Traditional | PDF ↗ |
| K964304 | OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY | Osteonics Corp. | 1997-01-17 | Traditional | PDF ↗ |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | Buckman Co., Inc. | 1997-01-16 | Traditional | PDF ↗ |
| K963357 | MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE | Synthes (Usa) | 1997-01-09 | Traditional | PDF ↗ |
| K964007 | ACROMED CABLE/WIRE PEDICLE SCREW | Acromed Corp. | 1996-12-16 | Traditional | PDF ↗ |
| K962608 | SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR | Synthes (Usa) | 1996-12-09 | Traditional | PDF ↗ |
| K962645 | ISOLA TWISTER CONNECTOR | Acromed Corp. | 1996-10-22 | Traditional | PDF ↗ |
| K962784 | ULTIUM SPINAL PLATING SYSTEM | Smith & Nephew, Inc., Orthopaedic Div. | 1996-10-02 | Traditional | PDF ↗ |
| K962757 | J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP | J.B.S., S.A. | 1996-09-25 | Traditional | PDF ↗ |
| K961572 | VERSALOK SCREW ASSEMBLY (PROPOSED NAME) | Wrightmedicaltechnologyinc | 1996-09-17 | Traditional | PDF ↗ |
| K960107 | DDS SPINAL SYSTEM | Encore Orthopedics, Inc. | 1996-05-03 | Traditional | PDF ↗ |
| K960451 | WEBB-MORLEY SPINE SYSTEM | Buckman Co., Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K953881 | SPINE SYSTEM SACRAL PLATE | J.B.S., S.A. | 1996-02-21 | Traditional | PDF ↗ |
| K953915 | MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) | Depuy, Inc. | 1996-02-15 | Traditional | PDF ↗ |
| K950717 | AUGMENT-T POSTERIOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K943827 | SPINE FIXATION | Danek Medical, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Buckman Co., Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K952236 | ISOLA SYSTEM | Acromed Corp. | 1996-01-22 | Traditional | PDF ↗ |
| K952298 | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE | J.B.S., S.A. | 1995-12-13 | Traditional | PDF ↗ |
| K951266 | AMSET R-F SYSTEM | Advanced Spine Technology, Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K953779 | SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM | Advanced Spine Fixation Systems, Inc. | 1995-11-07 | Traditional | PDF ↗ |
| K953778 | SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM | Advanced Spine Fixation Systems, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K953635 | TITANIUM DYNA-LOK SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K953416 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | Arcan Orthopaedic Corp. | 1995-10-03 | Traditional | PDF ↗ |
| K953369 | STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW | Advanced Spine Fixation Systems, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K951725 | OSTEONICS SPINAL SYSTEM | Osteonics Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K950865 | ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT | Smith & Nephew Richards, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K950596 | GDLH POSTERIOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K950955 | PARAGON POSTERIOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K951626 | SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM | Synthes (Usa) | 1995-08-21 | Traditional | PDF ↗ |
| K951794 | SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) | Synthes (Usa) | 1995-08-21 | Traditional | PDF ↗ |
| K951657 | VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) | Acromed Corp. | 1995-08-21 | Traditional | PDF ↗ |
| K936307 | DYNA-LOK ANTERIOR PLATING SYSTEM | Danek Group, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K950074 | WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM | Wrightmedicaltechnologyinc | 1995-08-11 | Traditional | PDF ↗ |
| K951116 | ACROMED PEDICLE SCREW | Acromed Corp. | 1995-08-11 | Traditional | PDF ↗ |
| K946348 | TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) | Sofamor Danek USA,Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K951308 | 5.8MM DIAMETER ANCHOR SCREW | Advanced Spine Fixation Systems, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K951172 | TITANIUM LOW PROFILE CROSS BAR | Advanced Spine Fixation Systems, Inc. | 1995-07-25 | Traditional | PDF ↗ |
| K950695 | DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION | Depuy Motech | 1995-07-21 | Traditional | PDF ↗ |
| K940631 | CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM | Cross Medical Products, Inc. | 1995-07-13 | Traditional | PDF ↗ |
| K950697 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION | Depuy Motech | 1995-06-22 | Traditional | PDF ↗ |
Product code MNH · Class II · Orthopedic. Data: openFDA.