The following data is part of a premarket notification filed by F & A Foundation Llc D.b.a. Reign Medical with the FDA for Clench Compression Staple.
| Device ID | K173775 |
| 510k Number | K173775 |
| Device Name: | Clench Compression Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | F & A Foundation LLC D.b.a. Reign Medical 6303 E 102nd Street Suite 200 Tulsa, OK 74137 |
| Contact | Daniel Lanois |
| Correspondent | Daniel Lanois SurgOp Support LLC 3270 Walton Riverwood Lane SE #4025 Atlanta, GA 30339 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-12 |
| Decision Date | 2018-04-06 |
| Summary: | summary |