The following data is part of a premarket notification filed by Miami Device Solutions, Llc with the FDA for Cannulated Screw.
| Device ID | K161058 |
| 510k Number | K161058 |
| Device Name: | Cannulated Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | MIAMI DEVICE SOLUTIONS, LLC 7620 NW 25TH STREET UNIT 3 Miami, FL 33122 |
| Contact | Markku Biedermann |
| Correspondent | Robert Poggie BIOVERA INC. 65 PROMENADE SAINT LOUIS Notre-dame-de-l'ile-perrot, CA J7v7p2 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-07-29 |
| Summary: | summary |