Medical Device Manufacturer · US , Mchenry , IL

Synthes (Usa)

411 submissions · 394 cleared · Since 1977
411
Total
394
Cleared
0
Denied

Synthes (Usa) — FDA 510(k) Submissions

Synthes (Usa) has submitted 411 FDA 510(k) premarket notifications since 1977, of which 394 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Plate, Bone, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Screw, Fixation, Bone, Rod, Fixation, Intramedullary And Accessories . Use the specialty filter in the sidebar to narrow results.

411 devices
1–25 of 411
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2015 294d
SYNTHES SYNSONIC ULNA NAIL
K131984 · HSB Rod, Fixation,... · Orthopedic
Mar 2014 276d
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2012 35d
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2012 89d
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
K120717 · HRS Plate, Fixation, Bone · Orthopedic
May 2012 61d
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2012 72d
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · HSB Rod, Fixation,... · Orthopedic
Feb 2012 28d
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · JDS Nail, Fixation, Bone · Orthopedic
Dec 2011 174d
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2011 67d
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · JDQ Cerclage, Fixation · Orthopedic
Jul 2011 128d
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2011 145d
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2011 93d
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
K110354 · JDP Condylar Plate Fixation... · Orthopedic
Mar 2011 25d
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · HSB Rod, Fixation,... · Orthopedic
Mar 2011 145d
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2011 81d
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · JEY Plate, Bone · Dental
Dec 2010 96d
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · OAT Implant, Endosseous,... · Dental
Dec 2010 421d
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2010 80d
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2010 138d
SYNTHES MATRIX SYSTEM
K100634 · NKB Thoracolumbosacral... · Orthopedic
Jul 2010 118d
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
K092190 · KTT Appliance, Fixation,... · Orthopedic
May 2010 294d
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
K092812 · HRS Plate, Fixation, Bone · Orthopedic
May 2010 239d
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361 · HBB Motor, Drill, Pneumatic · Neurology
Apr 2010 168d
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2010 29d
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2010 97d

Looking for a specific device from Synthes (Usa)? Search by device name or K-number.

Search all Synthes (Usa) devices
Filters