The following data is part of a premarket notification filed by Medshape, Inc. with the FDA for Dynaclip Bone Staple.
| Device ID | K193305 |
| 510k Number | K193305 |
| Device Name: | DynaClip Bone Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | MedShape, Inc. 1575 Northside Drive NW, Suite 440 Atlanta, GA 30318 |
| Contact | Jack Griffis |
| Correspondent | Jack Griffis MedShape, Inc. 1575 Northside Drive NW, Suite 440 Atlanta, GA 30318 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2020-04-23 |