The following data is part of a premarket notification filed by Ceterix Orthopaedics, Inc. with the FDA for Novostitch Plus Meniscal Repair System.
| Device ID | K143356 |
| 510k Number | K143356 |
| Device Name: | NovoStitch Plus Meniscal Repair System |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Ceterix Orthopaedics, Inc. 959 Hamilton Ave Menlo Park, CA 94025 |
| Contact | Michael Hendricksen |
| Correspondent | Michael Hendricksen Ceterix Orthopaedics, Inc. 959 Hamilton Ave Menlo Park, CA 94025 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853541006082 | K143356 | 000 |