Depuyacromed
Medical device manufacturer in Raynham, MA.
48510(k) clearances
0PMA approvals
0recalls
Device types
- MNH Orthosis, Spondylolisthesis Spinal Fixation 13
- KWP Appliance, Fixation, Spinal Interlaminal 10
- MQP Spinal Vertebral Body Replacement Device 8
- MNI Orthosis, Spinal Pedicle Fixation 6
- KWQ Appliance, Fixation, Spinal Intervertebral… 4
- LYC Bone Grafting Material, Synthetic 2
- JEC Component, Traction, Invasive 1
- GEY Motor, Surgical Instrument, Ac-Powered 1
- MRW System, Facet Screw Spinal Device 1
- MQV Filler, Bone Void, Calcium Compound 1
- FMF Syringe, Piston 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K040197 | Eagle Anterior Cervial Plate SystemKWQ · Special | 04/02/2004SE |
| K031635 | Depuy Acromed VBR SystemMQP · Special | 06/23/2003SE |
| K030833 | Depuy Acromed VBR SystemMQP · Special | 04/10/2003SE |
| K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsMNH · Special | 02/26/2003SE |
| K030249 | Surgical Titanium Mesh SystemMQP · Special | 02/14/2003SE |
| K030103 | Summit Oct Spinal System Minipolyaxial ScrewsMNI · Special | 02/05/2003SE |
| K023835 | Devex Mesh SystemMQP · Special | 01/29/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | 01/28/2003SE |
| K023804 | Moss Miami Spinal System Pin NutKWP · Special | 01/23/2003SE |
| K021039 | Bowti Anterior Buttress Staple SystemKWQ · Traditional | 12/11/2002SE |
| K023438 | Modification to Monarch Spine SystemMNH · Special | 11/13/2002SE |
| K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)KWP · Special | 08/27/2002SE |
| K022285 | Modification to Isola Spinal SystemMNI · Special | 08/13/2002SE |
| K022246 | Modification to Symphony Graft Delivery SystemFMF · Special | 08/02/2002SE |
| K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemMNI · Special | 07/24/2002SE |
| K021335 | Monarch Spine SystemMNH · Traditional | 07/11/2002SE |
| K021880 | Crossover Cross Connector (Moss Miami Spine System)MNH · Special | 06/26/2002SE |
| K021879 | Crossover Cross Connector (Isola Spinal System)MNH · Special | 06/26/2002SE |
| K021148 | Monarch Spine System Commercially Pure Titanium Spinal RodMNH · Special | 05/08/2002SE |
| K020522 | Modification to Surgical Titanium Mesh SystemMQP · Special | 03/21/2002SE |
| K014053 | Conduit TCP GranulesMQV · Traditional | 03/08/2002SE |
| K013441 | Isola Polyaxial WasherKWP · Special | 11/16/2001SE |
| K012773 | Discovery Facet Screw Fixation SystemMRW · Traditional | 11/16/2001SE |
| K012738 | Symphony Graft Delivery System (GDS)GEY · Traditional | 11/14/2001SE |
| K013382 | Modification to: Stackable Cage SystemMQP · Special | 11/07/2001SE |
| K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemMNI · Traditional | 11/07/2001SE |
| K013296 | Moss Miami Spinal SystemsMNH · Special | 10/09/2001SE |
| K013295 | Timx Spinal SystemsMNH · Special | 10/09/2001SE |
| K013294 | Monarch Spinal SystemsMNH · Special | 10/09/2001SE |
| K012971 | Isola Spinal SystemsMNH · Special | 10/05/2001SE |
| K010681 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemKWP · Traditional | 07/18/2001SE |
| K010972 | Isola Band ClampMNI · Special | 06/12/2001SE |
| K010576 | Monarch Spine SystemMNI · Traditional | 05/23/2001SE |
| K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsMNH · Special | 05/16/2001SE |
| K003043 | Surgical Titanium Mesh SystemMQP · Traditional | 05/08/2001SE |
| K010742 | Moss Miami 5.5MM Titanium Pin NutMNH · Special | 04/12/2001SE |
| K010320 | Modification to Symphony Graft Delivery SystemLYC · Special | 03/01/2001SE |
| K003286 | Symphony Graft Delivery SystemLYC · Traditional | 01/18/2001SE |
| K003822 | Isola Closed Dual Rod ConnectorKWP · Special | 01/08/2001SE |
| K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemKWP · Traditional | 12/15/2000SE |
| K002607 | Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral…KWP · Special | 09/12/2000SE |
| K001470 | E-Z Link Cross ConnectorKWP · Traditional | 08/04/2000SE |
| K001372 | E-Z Link Cross ConnectorKWP · Traditional | 07/27/2000SE |
| K001340 | Stackable Cage SystemMQP · Traditional | 07/26/2000SE |
| K001105 | Moss Miami 6.35MM Rod System Pedicle and Laminar HooksKWP · Special | 04/24/2000SE |
| K993030 | Modification to Isola Spinal SystemKWQ · Traditional | 12/29/1999SE |
| K993099 | Bremer Halo System Titanium Skull PinJEC · Traditional | 12/15/1999SE |
| K992168 | Moss Miami 6.35MM Polyaxial ScrewKWQ · Traditional | 09/23/1999SE |