Company ยท US
Etex Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2024. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| 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 |
| FMF | Syringe, Piston | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2024 | K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) Etex Corporation | MQV |
| Aug 31, 2018 | K182107 | CarriGen PF Etex Corporation | MQV |
| Feb 20, 2015 | K132868 | CARRICELL Etex Corporation | MQV |
| Jul 9, 2014 | K141245 | ETEX MIXING AND DELIVERY SYSTEM Etex Corporation | FMF |
| Dec 21, 2010 | K100883 | CARRIGEN Etex Corp. | LYC |
| Dec 3, 2010 | K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE Etex Corporation | LYC |
| Jul 1, 2010 | K101557 | GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN Etex Corp. | MQV |
| Feb 18, 2010 | K093447 | CARRIGEN Etex Corp. | MQV |
| Dec 23, 2009 | K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE Etex Corp. | LYC |
| Nov 2, 2009 | K091607 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE Etex Corp. | MQV |
| Sep 18, 2009 | K090855 | EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE Etex Corp. | MQV |
| Mar 24, 2009 | K090310 | EQUIVABONE Etex Corp. | MQV |
| Feb 20, 2009 | K090242 | GAMMA-BSM, BETA-BSM Etex Corp. | MQV |
| Apr 28, 2008 | K080329 | CAP PLUS, EQUIVABONE, CAP/DBM Etex Corp. | MBP |
| Nov 19, 2007 | K063050 | CAP PLUS Etex Corp. | MQV |
| Oct 23, 2007 | K072636 | A-BSM BONE SUBSTITUTE MATERIAL Etex Corp. | MQV |
| Sep 26, 2007 | K072355 | OSSIFUSE BONE SUBSTITUTE MATERIAL Etex Corp. | MQV |
| Jun 28, 2007 | K062630 | OSSIPRO BONE SUBSTITUTE MATERIAL Etex Corp. | MQV |
| Dec 2, 2003 | K033138 | CAP3 BONE SUBSTITUTE MATERIAL Etex Corp. | MQV |
| Oct 24, 2003 | K032307 | CAP BONE SUBSTITUTE MATERIAL Etex Corp. | GXP |
| Nov 25, 1998 | K983009 | BSM- BONE SUBSTITUTE MATERIAL Etex Corp. | GXP |
| Aug 5, 1997 | K962548 | BSM BONE SUBSTITUTE MATERIAL KIT Etex Corp. | LYC |
| Jul 22, 1994 | K935696 | ETEX HA HIP REPLACEMENT SYSTEM Etex Corp. | MEH |
| Feb 9, 1993 | K925895 | ETEX HIP REPLACEMENT SYSTEM Etex Co. | JDI |
| Feb 19, 1992 | K913417 | ETEX DENTAL IMPLANT SYSTEM Etex Co. | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||