EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
Etex Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1225112 | 3000206397 | ETEX Corporation | 1 | N | 2026-01-01 | 55 Messina Dr Braintree MA US 02184 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00889024205444 | AccuFill® - 201.050 | +1(877)383-9276 | sales@etexcorp.com |
| 00889024205567 | CarriGen ® - 76-6036 | 877-383-9276 | sales@etexcorp.com |
| 00889024406476 | AccuFill® - 201.030 | +1(877)383-9276 | sales@etexcorp.com |
| 00889024432826 | CarriGen - 76-6035 | 877-383-9276 | sales@etexcorp.com |
| 00889024563278 | N-Force Blue ™ - IN050-7 | 18003489500 | customerservice@zimmerbiomet.com |
| 00889024563285 | N-Force Blue ™ - IN050-8 | 18003489500 | customerservice@zimmerbiomet.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72778 | 1278447664 | K983009 | BSM- BONE SUBSTITUTE MATERIAL | GXP | 1998-11-25 |
| 72778 | 1509570938 | K962548 | BSM BONE SUBSTITUTE MATERIAL KIT | LYC | 1997-08-05 |
| 72778 | 1623319877 | K190814 | AccuFill Bone Substitute Material | MQV | 2019-06-10 |
| 72778 | 1321235191 | K182107 | CarriGen PF | MQV | 2018-08-31 |
| 72778 | 1278951368 | K141245 | ETEX MIXING AND DELIVERY SYSTEM | FMF | 2014-07-09 |
| 72778 | 1591472998 | K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE | LYC | 2010-12-03 |
| 72778 | 1451680667 | K101557 | GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN | MQV | 2010-07-01 |
| 72778 | 1391322783 | K093447 | CARRIGEN | MQV | 2010-02-18 |
| 72778 | 1310360197 | K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | LYC | 2009-12-23 |
| 72778 | 1378875369 | K090855 | EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE | MQV | 2009-09-18 |
| 72778 | 1855766815 | K090310 | EQUIVABONE | MQV | 2009-03-24 |
| 72778 | 1075914191 | K080329 | CAP PLUS, EQUIVABONE, CAP/DBM | MBP | 2008-04-28 |
| 72778 | 1773841250 | K072636 | A-BSM BONE SUBSTITUTE MATERIAL | MQV | 2007-10-23 |
| 72778 | 1280467799 | K072355 | OSSIFUSE BONE SUBSTITUTE MATERIAL | MQV | 2007-09-26 |
| 72778 | 1048038711 | K063050 | CAP PLUS | MQV | 2007-11-19 |
| 72778 | 1233119610 | K032307 | CAP BONE SUBSTITUTE MATERIAL | GXP | 2003-10-24 |
| 72778 | 1048038711 | ||||
| 72778 | 1148985614 | ||||
| 72778 | 1166235789 | ||||
| 72778 | 1321235191 | ||||
| 72778 | 1378875369 | ||||
| 72778 | 1451991576 | ||||
| 72778 | 1509570938 | ||||
| 72778 | 1765915079 | ||||
| 72778 | 1855766815 | ||||
| 72778 | 2010612752 |
Etex Corporation
ETEX Corporation
ETEX CORPORATION
ETEX CORPORATION
ETEX CORPORATION
2015-11-02
2015-11-02
2019-12-18
2019-12-18
2019-12-16
2019-12-16
2015-10-24
2016-06-02
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2019-01-23
2019-01-23
2019-01-28
2019-01-28
2015-10-24
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2015-10-24
2015-10-24
2015-10-24