The following data is part of a premarket notification filed by Pisharodi Surgicals, Inc. with the FDA for Modification To Universal Multiaxis (unimax) Pedicle Screw System.
| Device ID | K024313 |
| 510k Number | K024313 |
| Device Name: | MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-24 |
| Decision Date | 2003-08-29 |
| Summary: | summary |