SYGNAL DBM
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
MUSCULOSKELETAL TRANSPLANT FOUNDATION
The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Sygnal Dbm.
Pre-market Notification Details
| Device ID | K080405 |
| 510k Number | K080405 |
| Device Name: | SYGNAL DBM |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Contact | Nancy Bennewitz Joy |
| Correspondent | Nancy Bennewitz Joy MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-14 |
| Decision Date | 2008-08-28 |
| Summary: | summary |
Trademark Results [SYGNAL DBM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYGNAL DBM 76679608 not registered Dead/Abandoned |
MUSCULOSKELETAL TRANSPLANT FOUNDATION 2007-07-17 |
 SYGNAL DBM 75906265 not registered Dead/Abandoned |
MUSCULOSKELETAL TRANSPLANT FOUNDATION 2000-01-31 |
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