The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Modification To Vertebron Pss Pedicle Screw System.
| Device ID | K081597 |
| 510k Number | K081597 |
| Device Name: | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | VERTEBRON, INC. 400 LONG BEACH BLVD. Stratford, CT 06615 |
| Contact | Luis Nesprido |
| Correspondent | Luis Nesprido VERTEBRON, INC. 400 LONG BEACH BLVD. Stratford, CT 06615 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-06 |
| Decision Date | 2008-07-02 |
| Summary: | summary |