The following data is part of a premarket notification filed by Ulrich Medical Usa with the FDA for Solidity Vertebral Body Replacement.
Device ID | K181921 |
510k Number | K181921 |
Device Name: | Solidity Vertebral Body Replacement |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
Contact | Hans Stover |
Correspondent | Hans Stover ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-18 |
Decision Date | 2018-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00814386022668 | K181921 | 000 |
00814386022446 | K181921 | 000 |
00814386022439 | K181921 | 000 |
00814386022422 | K181921 | 000 |
00814386022415 | K181921 | 000 |
00814386022408 | K181921 | 000 |
00814386022392 | K181921 | 000 |
00814386022385 | K181921 | 000 |
00814386022378 | K181921 | 000 |
00814386022361 | K181921 | 000 |
00814386022354 | K181921 | 000 |
00814386022347 | K181921 | 000 |
00814386022330 | K181921 | 000 |
00814386022323 | K181921 | 000 |
00814386022316 | K181921 | 000 |
00814386022309 | K181921 | 000 |
00814386022293 | K181921 | 000 |
00814386022286 | K181921 | 000 |
00814386022453 | K181921 | 000 |
00814386022460 | K181921 | 000 |
00814386022477 | K181921 | 000 |
00814386022651 | K181921 | 000 |
00814386022644 | K181921 | 000 |
00814386022637 | K181921 | 000 |
00814386022620 | K181921 | 000 |
00814386022613 | K181921 | 000 |
00814386022606 | K181921 | 000 |
00814386022590 | K181921 | 000 |
00814386022583 | K181921 | 000 |
00814386022569 | K181921 | 000 |
00814386022552 | K181921 | 000 |
00814386022545 | K181921 | 000 |
00814386022538 | K181921 | 000 |
00814386022521 | K181921 | 000 |
00814386022514 | K181921 | 000 |
00814386022507 | K181921 | 000 |
00814386022491 | K181921 | 000 |
00814386022484 | K181921 | 000 |
00814386022279 | K181921 | 000 |