The following data is part of a premarket notification filed by Rotation Medical, Inc. with the FDA for Rotation Medical Bone Staple (rmb Staple).
| Device ID | K131635 |
| 510k Number | K131635 |
| Device Name: | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 Plymouth, MN 55447 |
| Contact | Gail Schroeder |
| Correspondent | Gail Schroeder ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 Plymouth, MN 55447 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2013-08-29 |
| Summary: | summary |