The following data is part of a premarket notification filed by Ceterix Orthopaedics, Inc. with the FDA for Novostitch Pro Meniscal Repair System, Ctx-a004 (size 0).
| Device ID | K181772 |
| 510k Number | K181772 |
| Device Name: | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Ceterix Orthopaedics, Inc. 6500 Kaiser Drive, Suite 120 Fremont, CA 94555 |
| Contact | Tarhan Kayihan |
| Correspondent | Tarhan Kayihan Ceterix Orthopaedics, Inc. 6500 Kaiser Drive, Suite 120 Fremont, CA 94555 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2018-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853541006068 | K181772 | 000 |
| 00853541006051 | K181772 | 000 |