The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Vertebron Pss Pedicle Screw System.
| Device ID | K033352 |
| 510k Number | K033352 |
| Device Name: | VERTEBRON PSS PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | VERTEBRON, INC. 136 ALBERT AVENUE Stratford, CT 06614 |
| Contact | Bruce Khalili |
| Correspondent | Bruce Khalili VERTEBRON, INC. 136 ALBERT AVENUE Stratford, CT 06614 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-20 |
| Decision Date | 2004-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B4179135100M1 | K033352 | 000 |
| B4179135220M1 | K033352 | 000 |
| B41792555301 | K033352 | 000 |
| B41792555351 | K033352 | 000 |
| B41792555401 | K033352 | 000 |
| B41792555451 | K033352 | 000 |
| B41792555501 | K033352 | 000 |
| B41792555551 | K033352 | 000 |
| B41792555601 | K033352 | 000 |
| B4179135210M1 | K033352 | 000 |
| B4179135200M1 | K033352 | 000 |
| B4179135190M1 | K033352 | 000 |
| B4179135110M1 | K033352 | 000 |
| B4179135120M1 | K033352 | 000 |
| B4179135130M1 | K033352 | 000 |
| B4179135140M1 | K033352 | 000 |
| B4179135150M1 | K033352 | 000 |
| B4179135160M1 | K033352 | 000 |
| B4179135170M1 | K033352 | 000 |
| B4179135180M1 | K033352 | 000 |
| B41792565301 | K033352 | 000 |
| B41792565351 | K033352 | 000 |
| B41792575601 | K033352 | 000 |
| B41792585301 | K033352 | 000 |
| B41792585351 | K033352 | 000 |
| B41792585401 | K033352 | 000 |
| B41792585451 | K033352 | 000 |
| B41792585501 | K033352 | 000 |
| B41792585551 | K033352 | 000 |
| B41792585601 | K033352 | 000 |
| B41792575551 | K033352 | 000 |
| B41792575501 | K033352 | 000 |
| B41792575451 | K033352 | 000 |
| B41792565401 | K033352 | 000 |
| B41792565451 | K033352 | 000 |
| B41792565501 | K033352 | 000 |
| B41792565551 | K033352 | 000 |
| B41792565601 | K033352 | 000 |
| B41792575301 | K033352 | 000 |
| B41792575351 | K033352 | 000 |
| B41792575401 | K033352 | 000 |
| 00843210112022 | K033352 | 000 |