The following data is part of a premarket notification filed by Mbd Medical, Llc with the FDA for Mbd Plate System.
| Device ID | K141045 |
| 510k Number | K141045 |
| Device Name: | MBD PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MBD MEDICAL, LLC 575 EIGHTH AVENUE, SUITE 1212 New York, NY 10018 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin MBD MEDICAL, LLC 575 EIGHTH AVENUE, SUITE 1212 New York, NY 10018 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-23 |
| Decision Date | 2014-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852406006205 | K141045 | 000 |
| 00852406006083 | K141045 | 000 |
| 00852406006076 | K141045 | 000 |
| 00852406006069 | K141045 | 000 |
| 00852406006052 | K141045 | 000 |
| 00852406006045 | K141045 | 000 |
| 00852406006038 | K141045 | 000 |
| 00852406006021 | K141045 | 000 |
| 00852406006014 | K141045 | 000 |
| 00852406006090 | K141045 | 000 |
| 00852406006106 | K141045 | 000 |
| 00852406006113 | K141045 | 000 |
| 00852406006199 | K141045 | 000 |
| 00852406006182 | K141045 | 000 |
| 00852406006175 | K141045 | 000 |
| 00852406006168 | K141045 | 000 |
| 00852406006151 | K141045 | 000 |
| 00852406006144 | K141045 | 000 |
| 00852406006137 | K141045 | 000 |
| 00852406006120 | K141045 | 000 |
| 00852406006007 | K141045 | 000 |