The following data is part of a premarket notification filed by Anika Therapeutics, Inc. with the FDA for Scs 17-01.
| Device ID | K173008 |
| 510k Number | K173008 |
| Device Name: | SCS 17-01 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Anika Therapeutics, Inc. 32 Wiggins Avenue Bedford, MA 01730 |
| Contact | Steven Chartier |
| Correspondent | Steven Chartier Musculoskeletal Clinical Regulatory Advisers, LLC 32 Wiggins Avenue Bedford, MA 01730 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817337000074 | K173008 | 000 |
| 00817337000050 | K173008 | 000 |