510(k) K080329
- Device
- CAP PLUS, EQUIVABONE, CAP/DBM
- Applicant
- ETEX CORP.
- 510(k) number
- K080329
- Product code
- MBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-28
- Date received
- 2008-02-07
- Regulation
- 888.3045
- Classification name
- Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA W ADAMS
- Address
- 38 Sidney St., 3flr The Clark Bldg. Cambridge MA US 02139 02139
FDA Registration Numbers#
- 1220246
- 2031966
- 3009144915
- 3014211822
- 3012161787
- 3010560653
- 1032347
- 2249062
- 2029275
- 2024024
- 3005064037
- 3009882464
- 1220477
- 3008522639
- 3008650117
- 3012448339
- 3015231789
- 3012447612
- 3016050940
- 3003477135
- 3008812241
- 1450662
- 2030598
- 3005381997
- 3000215346
- 1225112
- 3005031160
- 1030489
- 3010667733
- 1038671
- 1424263
- 3016851379
- 1222747
- 1825034
- 3014078231
- 1000307092
- 1226544
- 3018094310
- 2090010
- 2011171
- 3009672666
- 3010331645
- 3010376334
- 1216032
- 3003828812
- 1043534
- 1319660
- 2249915
- 2245304
- 3002719998
- 3012102437
- 3015724777
Source Documents#
Other 510(k) Records For Product Code MBP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242799 | PliaFX Flo | Lifenet Health | 2024-11-21 |
| K143547 | Vivorte Trabexus EB | Vivorte, Inc. | 2015-01-14 |
| K130703 | VIVORTE BVF | Vivorte, Inc. | 2013-09-12 |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | 2013-05-31 |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Medtronic Sofamor Danek, Inc. | 2013-03-06 |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | Hans Biomed Corp. | 2012-11-15 |
| K103742 | ACCELL EVO3 (FORMERLY ACCELL A2I) | Integra Life Sciences | 2011-03-17 |
| K091193 | ACCELL EVO3C | Isotis Orthobiologics, Inc. | 2009-08-10 |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Musculoskeletal Transplant Foundation | 2008-10-10 |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | 2008-09-24 |
| K080405 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-08-28 |
| K073329 | SYGNAL DBM | Musculoskeletal Transplant Foundation | 2008-02-28 |
| K063685 | OPTECURE; OPTECURE + CCC | Exactech, Inc. | 2007-06-07 |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | Musculoskeletal Transplant Foundation | 2007-03-05 |
| K061131 | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | Orthocon, Inc. | 2007-02-08 |
Legacy Summary#
summary
FDA Review#
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