The following data is part of a premarket notification filed by Pisharodi Surgicals, Inc. with the FDA for Radix Cervical Plate.
| Device ID | K033951 |
| 510k Number | K033951 |
| Device Name: | RADIX CERVICAL PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | PISHARODI SURGICALS, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J. D Webb |
| Correspondent | J. D Webb PISHARODI SURGICALS, INC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-07-01 |
| Summary: | summary |