The following data is part of a premarket notification filed by Rivarp Medical Private Limited with the FDA for Kentrospine Pss Pedicle Screw System.
| Device ID | K220486 |
| 510k Number | K220486 |
| Device Name: | Kentrospine PSS Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Rivarp Medical Private Limited No.34, Azeez Sait Industrial Town, 6th Mile, Mysore Road,Nayandahalli. Bangalore, IN 560039 |
| Contact | Sushma N.R |
| Correspondent | Sushma N.R Rivarp Medical Private Limited No.34, Azeez Sait Industrial Town, 6th Mile, Mysore Road,Nayandahalli. Bangalore, IN 560039 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-07-22 |