Medical Device Manufacturer · US , Raynham , MA

Depuyacromed

48 submissions · 48 cleared · Since 1999
48
Total
48
Cleared
0
Denied

Depuyacromed — FDA 510(k) Submissions

Depuyacromed has submitted 48 FDA 510(k) premarket notifications since 1999, of which 48 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Orthosis, Spondylolisthesis Spinal Fixation, Appliance, Fixation, Spinal Interlaminal, Spinal Vertebral Body Replacement Device, Orthosis, Spinal Pedicle Fixation, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · KWQ Appliance, Fixation,... · Orthopedic
Apr 2004 64d
DEPUY ACROMED VBR SYSTEM
K031635 · MQP Spinal Vertebral Body... · Orthopedic
Jun 2003 27d
DEPUY ACROMED VBR SYSTEM
K030833 · MQP Spinal Vertebral Body... · Orthopedic
Apr 2003 24d
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · MNH Orthosis,... · Orthopedic
Feb 2003 21d
SURGICAL TITANIUM MESH SYSTEM
K030249 · MQP Spinal Vertebral Body... · Orthopedic
Feb 2003 21d
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Feb 2003 23d
DEVEX MESH SYSTEM
K023835 · MQP Spinal Vertebral Body... · Orthopedic
Jan 2003 72d
MONARCH SPINE SYSTEM
K024348 · MNH Orthosis,... · Orthopedic
Jan 2003 29d
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · KWP Appliance, Fixation,... · Orthopedic
Jan 2003 70d
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2002 254d
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · MNH Orthosis,... · Orthopedic
Nov 2002 29d
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · KWP Appliance, Fixation,... · Orthopedic
Aug 2002 20d
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Aug 2002 29d
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · FMF Syringe, Piston · General Hospital
Aug 2002 21d
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Jul 2002 19d
MONARCH SPINE SYSTEM
K021335 · MNH Orthosis,... · Orthopedic
Jul 2002 76d
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879 · MNH Orthosis,... · Orthopedic
Jun 2002 19d
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880 · MNH Orthosis,... · Orthopedic
Jun 2002 19d
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K021148 · MNH Orthosis,... · Orthopedic
May 2002 28d
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · MQP Spinal Vertebral Body... · Orthopedic
Mar 2002 30d
CONDUIT TCP GRANULES
K014053 · MQV Filler, Bone Void,... · Orthopedic
Mar 2002 88d
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · MRW System, Facet Screw... · Orthopedic
Nov 2001 88d
ISOLA POLYAXIAL WASHER
K013441 · KWP Appliance, Fixation,... · Orthopedic
Nov 2001 30d
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K012738 · GEY Motor, Surgical... · General & Plastic Surgery
Nov 2001 90d
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
K013222 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Nov 2001 41d
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