SYGNAL DBM
FDA 510(k) clearance K080405 · decided 2008-08-28
Clearance details
- K-number
- K080405
- Device name
- SYGNAL DBM
- Applicant
- Musculoskeletal Transplant Foundation
- Decision
- Substantially Equivalent
- Date received
- 2008-02-14
- Decision date
- 2008-08-28
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MBP
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| PliaFX Flo (K242799) | Lifenet Health | 2024-11-21 |
| Vivorte Trabexus EB (K143547) | Vivorte, Inc. | 2015-01-14 |
| VIVORTE BVF (K130703) | Vivorte, Inc. | 2013-09-12 |
| OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (K130498) | Bacterin International, Inc. | 2013-05-31 |
| CLEARED UNDER GRAFTON II EDBM (K122513) | Medtronic Sofamor Danek, Inc. | 2013-03-06 |
| SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (K113728) | Hans Biomed Corp. | 2012-11-15 |
| ACCELL EVO3 (FORMERLY ACCELL A2I) (K103742) | Integra Life Sciences | 2011-03-17 |
| ACCELL EVO3C (K091193) | Isotis Orthobiologics, Inc. | 2009-08-10 |
| DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (K080399) | Musculoskeletal Transplant Foundation | 2008-10-10 |
| ACCELL TBM-R (K081817) | Isotis Orthobiologics, Inc. | 2008-09-24 |
| CAP PLUS, EQUIVABONE, CAP/DBM (K080329) | Etex Corp. | 2008-04-28 |
| SYGNAL DBM (K073329) | Musculoskeletal Transplant Foundation | 2008-02-28 |
Recalls involving this device
No recalls on record reference this clearance.