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 |