The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Aft Allograft Filler Tube.
Device ID | K060161 |
510k Number | K060161 |
Device Name: | AFT ALLOGRAFT FILLER TUBE |
Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
Contact | Nancy Bennewitz |
Correspondent | Nancy Bennewitz 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 | 2006-01-20 |
Decision Date | 2006-03-21 |
Summary: | summary |