The following data is part of a premarket notification filed by Radicle Orthopaedics, Inc. with the FDA for Rasl Repair Kit.
| Device ID | K161334 |
| 510k Number | K161334 |
| Device Name: | RASL Repair Kit |
| Classification | Screw, Fixation, Bone |
| Applicant | RADICLE ORTHOPAEDICS, INC. PO BOX 7551 New York, NY 10150 |
| Contact | Edward Rosenwasser |
| Correspondent | John Kapitan Kapstone Medical, LLC P.O. Box 969 Leicester, NC 28748 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-12 |
| Decision Date | 2017-02-09 |
| Summary: | summary |