The following data is part of a premarket notification filed by Medos Sarl with the FDA for Isola And Expedium Growing Spine Systems.
| Device ID | K141509 |
| 510k Number | K141509 |
| Device Name: | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS |
| Classification | Growing Rod System |
| Applicant | MEDOS SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kirsten Lehmuller |
| Correspondent | Kirsten Lehmuller MEDOS SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | PGM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-06 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034116587 | K141509 | 000 |
| 10705034116570 | K141509 | 000 |
| 10705034116563 | K141509 | 000 |
| 10705034109145 | K141509 | 000 |
| 10705034109138 | K141509 | 000 |
| 10705034109121 | K141509 | 000 |
| 10705034011790 | K141509 | 000 |
| 10705034011783 | K141509 | 000 |
| 10705034011776 | K141509 | 000 |