Synthes (Usa)
Synthes (Usa) holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2015, with 2 FDA device recalls on record.
Name variants for Synthes (Usa)
as filed with FDA- Synthes (Usa)
- Synthes USA
Top product codes for Synthes (Usa)
FDA recalls by Synthes (Usa)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Synthes (Usa)
1–100 of 411- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
- K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
- K120083 — SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
- K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
- K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
- K110789 — SYNTHES STERNAL ZIPFIX SYSTEM
- K110592 — 3.7MM/5.0MM DYNAMIC LOCKING SCREW
- K110125 — 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
- K110354 — 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
- K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
- K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
- K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
- K093299 — SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
- K102694 — 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
- K100776 — SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
- K100634 — SYNTHES MATRIX SYSTEM
- K092190 — SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
- K092812 — SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
- K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM
- K100676 — SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
- K093928 — SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
- K093668 — SYNTHES MATRIX MIS RODS
- K090658 — SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
- K093464 — RAPIDSORB PLUS SCREW SYSTEM
- K092909 — SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
- K092929 — SYNTHES MATRIX SYSTEM
- K091644 — SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
- K091233 — SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
- K092556 — SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
- K092609 — SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
- K090605 — CLAMPFIX
- K092247 — SYNTHES LOCKING HAND PLATES
- K092646 — SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
- K091144 — SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
- K090949 — SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
- K091689 — SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
- K090241 — SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
- K082649 — SYNTHES 90 DEGREE SCREWDRIVER
- K090047 — SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
- K083388 — SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
- K083694 — SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
- K083573 — SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
- K083439 — SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
- K083025 — SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
- K083213 — SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
- K082625 — SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
- K082807 — SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS
- K082650 — SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
- K082335 — SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
- K082624 — SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
- K082072 — SYNTHES (USA) 3.5MM LCP HOOK PLATE
- K081623 — SYNTHES RIB FIXATION SYSTEM
- K081747 — MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- K082148 — SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION
- K081353 — SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
- K081452 — SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM
- K081700 — SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
- K073115 — ORTHOMESH
- K073303 — NORIAN DRILLABLE
- K081205 — SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
- K080522 — SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
- K080153 — SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
- K081071 — SYNTHES 6.5MM MIDFOOT FUSION BOLT
- K080331 — SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
- K080943 — SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
- K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
- K073402 — SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
- K073460 — SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
- K073135 — SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
- K072758 — SYNTHES (USA) 2.0MM TITANIUM T-PLATE
- K073186 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
- K072578 — SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
- K071046 — SYNTHES CHRONOS COMPOSITE
- K072095 — SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
- K071476 — SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
- K071264 — SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
- K071184 — SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
- K070946 — SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
- K070843 — SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
- K063790 — THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
- K070208 — SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
- K062872 — SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
- K063473 — SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
- K063832 — SYNTHES (USA) ELBOW HINGE FIXATOR
- K070294 — SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
- K062789 — SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
- K063181 — SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- K063049 — SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
- K062564 — SYNTHES LCP DISTAL FEMUR PLATES
- K061910 — SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
- K061973 — SYNTHES 3.5MM SPRING PLATE
- K061940 — SYNTHES LCP ANKLE ARTHRODESIS PLATES
- K062299 — SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
- K061753 — SYNTHES (USA) CLAVICLE HOOK PLATES
- K061621 — SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
- K060138 — SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.