Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
64510(k)s in 12 months (1,334 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Top companies in HRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes | 104 | 8 |
| Smith & Nephew | 37 | 16 |
| Biomet | 21 | 28 |
| Wrightmedicaltechnologyinc | 45 | 0 |
| Zimmer GmbH | 32 | 12 |
| Arthrex, Inc. | 40 | 3 |
| Wright Medical Technology Inc | 0 | 43 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 29, 2010 | K093928 | SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES Synthes (Usa) | HRS |
| Mar 29, 2010 | K093772 | SYNTHES STERNAL FIXATION SYSTEM Synthes | HRS |
| Mar 29, 2010 | K092493 | GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM Gpc Medical, Ltd., IN | HRS |
| Mar 19, 2010 | K093983 | SMPLE PLATE AND SCREWS Biomet Trauma (Aka Ebi, Lp) | HRS |
| Mar 10, 2010 | K094037 | TC PLATING SYSTEM Ortho-Pro, LLC | HRS |
| Mar 5, 2010 | K093761 | OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM Biomet Trauma (Aka Ebi, Lp) | HRS |
| Feb 17, 2010 | K093900 | EDGELOCK Orthohelix Surgical Designs, Inc. | HRS |
| Feb 5, 2010 | K091493 | ORTHO SELECT BONE PLATES AND SCREW SYSTEM Ortho Select Implant Technology Gesellschaft, NL | HRS |
| Feb 2, 2010 | K100146 | EVOLVE EPS ORTHOLOC Wrightmedicaltechnologyinc | HRS |
| Feb 2, 2010 | K093474 | DEPUY FRACTURE AND FUSION PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Jan 28, 2010 | K093433 | VARIAX ELBOW SYSTEM PLATE LINE EXTENSION Howmedica Osteonics Corp. | HRS |
| Jan 22, 2010 | K093950 | BIOFOAM BONE WEDGE MODEL ASSORTED Wrightmedicaltechnologyinc | HRS |
| Jan 22, 2010 | K093781 | MODIFIED: NEWDEAL HALLU PLATES Newdeal Sas | HRS |
| Dec 23, 2009 | K091644 | SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES Synthes (Usa) | HRS |
| Dec 15, 2009 | K093163 | INTEGRA TOTAL WRIST FUSION SYSTEM Integra LifeSciences Corporation | HRS |
| Nov 20, 2009 | K092178 | AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS Howmedica Osteonics Corp. | HRS |
| Nov 19, 2009 | K092670 | BIODRIVE MICRO SCREW SYSTEM Ebi,Llc D/B/A Biomet Trauma | HRS |
| Nov 17, 2009 | K092609 | SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) Synthes (Usa) | HRS |
| Nov 17, 2009 | K092556 | SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS Synthes (Usa) | HRS |
| Nov 5, 2009 | K082399 | PECTUS STRUT Koros USA, Inc. | HRS |
| Nov 2, 2009 | K092317 | DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM Deroyal Industries, Inc. | HRS |
| Oct 27, 2009 | K092381 | IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION Ibalance Medical, Inc. | HRS |
| Oct 27, 2009 | K090139 | ANKLE ARTHRODESIS PLATE SYSTEM Tornier, Inc. | HRS |
| Sep 25, 2009 | K092247 | SYNTHES LOCKING HAND PLATES Synthes (Usa) | HRS |
| Sep 23, 2009 | K092671 | VARIAX ELBOW SYSTEM LINE EXTENSION Howmedica Osteonics Corp. | HRS |
| Sep 10, 2009 | K091614 | OSTEOMED FOOT PLATING SYSTEM Osteomed LP | HRS |
| Sep 1, 2009 | K092419 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS Howmedica Osteonics Corp. | HRS |
| Aug 28, 2009 | K090304 | WAVEON WRX BONE FIXATION SYSTEM Sonoma Orthopedic Products, Inc. | HRS |
| Aug 5, 2009 | K092078 | OPTILOCK PERIARTICULAR PLATING Biomet Trauma | HRS |
| Jul 30, 2009 | K092015 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM Smith & Nephew, Inc. | HRS |
| Jul 24, 2009 | K091294 | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DePuy Orthopaedics, Inc. | HRS |
| Jul 22, 2009 | K091058 | ADKINS STRUT Biomet Microfixation, Inc. | HRS |
| Jul 15, 2009 | K091156 | TRIMED STERILE PRODUCT TriMed, Inc. | HRS |
| Jul 13, 2009 | K091479 | APTUS FOOT SYSTEM Medartis AG | HRS |
| Jul 10, 2009 | K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM Newdeal Sas | HRS |
| Jul 2, 2009 | K090582 | CALCANEAL FRACTURE PLATE SYSTEM Tornier, Inc. | HRS |
| Jul 2, 2009 | K090522 | OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM Osteomed LP | HRS |
| Jul 1, 2009 | K090983 | APTUS 2.0/2.3 FOUR CORNER FUSION PLATE Medartis AG | HRS |
| Jun 30, 2009 | K091609 | NEWDEAL COMPRESSION PLATE Newdeal Sas | HRS |
| Jun 26, 2009 | K091243 | ORTHOLOC ANKLE PLATING SYSTEM (APS) Wrightmedicaltechnologyinc | HRS |
| Jun 26, 2009 | K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DePuy Orthopaedics, Inc. | HRS |
| Jun 18, 2009 | K090786 | KENS INTERNAL FIXATION SYSTEM Kens Finemedtech Sdn. Bhd, MY | HRS |
| Jun 15, 2009 | K090289 | CLAVICLE PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jun 4, 2009 | K090675 | SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES Smith & Nephew, Inc. | HRS |
| May 20, 2009 | K090440 | HINGE PEDIATRIC PLATING SYSTEM Pega Medical, Inc., CA | HRS |
| May 8, 2009 | K090692 | ORTHOLOC 2.0/2.4 PLATE SYSTEM Wrightmedicaltechnologyinc | HRS |
| Apr 24, 2009 | K090839 | MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS Syntec Scientific Corp., TW | HRS |
| Apr 24, 2009 | K090666 | PEDIPLATES OrthoPediatrics Corp. | HRS |
| Apr 23, 2009 | K090053 | APTUS 2.0 RADIAL HEAD SYSTEM Medartis AG | HRS |
| Apr 1, 2009 | K090047 | SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM Synthes (Usa) | HRS |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.