The following data is part of a premarket notification filed by Vertebron, Inc. with the FDA for Vertebron Pss Pedicle Screw System.
Device ID | K051716 |
510k Number | K051716 |
Device Name: | VERTEBRON PSS PEDICLE SCREW SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
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 | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-27 |
Decision Date | 2005-09-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00843210121789 | K051716 | 000 |
B41792545601 | K051716 | 000 |
B41792545551 | K051716 | 000 |
B41792545501 | K051716 | 000 |
B41792545451 | K051716 | 000 |
B41792545401 | K051716 | 000 |
B41792545351 | K051716 | 000 |
B41792545301 | K051716 | 000 |