Etex Corp.
Medical device manufacturer in Braintree, MA.
25510(k) clearances
0PMA approvals
0recalls
Device types
- MQV Filler, Bone Void, Calcium Compound 14
- LYC Bone Grafting Material, Synthetic 4
- GXP Methyl Methacrylate For Cranioplasty 2
- DZE Implant, Endosseous, Root-Form 1
- JDI Prosthesis, Hip, Semi-Constrained… 1
- MEH Prosthesis, Hip, Semi-Constrained… 1
- MBP Filler, Bone Void, Osteoinduction (W/O… 1
- FMF Syringe, Piston 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )MQV · Special | 12/18/2024SE |
| K182107 | CarriGen PFMQV · Special | 08/31/2018SE |
| K132868 | CarricellMQV · Traditional | 02/20/2015SE |
| K141245 | Etex Mixing and Delivery SystemFMF · Traditional | 07/09/2014SE |
| K100883 | CarrigenLYC · Traditional | 12/21/2010SE |
| K102812 | Gamma-Bsm; Beta-Bsm; EquivaboneLYC · Special | 12/03/2010SE |
| K101557 | Gamma-Bsm, Beta-Bsm, Equivabone, CarigenMQV · Special | 07/01/2010SE |
| K093447 | CarrigenMQV · Special | 02/18/2010SE |
| K091729 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneLYC · Traditional | 12/23/2009SE |
| K091607 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, EquivaboneMQV · Traditional | 11/02/2009SE |
| K090855 | Equivabone Osteoinductive Bone Graft SubstituteMQV · Traditional | 09/18/2009SE |
| K090310 | EquivaboneMQV · Traditional | 03/24/2009SE |
| K090242 | Gamma-Bsm, Beta-BsmMQV · Special | 02/20/2009SE |
| K080329 | Cap Plus, Equivabone, Cap/DbmMBP · Traditional | 04/28/2008SE |
| K063050 | Cap PlusMQV · Traditional | 11/19/2007SE |
| K072636 | A-Bsm Bone Substitute MaterialMQV · Special | 10/23/2007SE |
| K072355 | Ossifuse Bone Substitute MaterialMQV · Special | 09/26/2007SE |
| K062630 | Ossipro Bone Substitute MaterialMQV · Traditional | 06/28/2007SE |
| K033138 | CAP3 Bone Substitute MaterialMQV · Traditional | 12/02/2003SE |
| K032307 | Cap Bone Substitute MaterialGXP · Traditional | 10/24/2003SE |
| K983009 | Bsm- Bone Substitute MaterialGXP · Traditional | 11/25/1998SE |
| K962548 | BSM Bone Substitute Material KitLYC · Traditional | 08/05/1997SE |
| K935696 | Etex Ha Hip Replacement SystemMEH · Traditional | 07/22/1994SN |
| K925895 | Etex Hip Replacement SystemJDI · Traditional | 02/09/1993SE |
| K913417 | Etex Dental Implant SystemDZE · Traditional | 02/19/1992SE |