The following data is part of a premarket notification filed by Joline Gmbh & Co. Kg with the FDA for Joline Kyphoplasty System Allevo.
| Device ID | K192449 |
| 510k Number | K192449 |
| Device Name: | Joline Kyphoplasty System Allevo |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Joline GmbH & Co. KG Neue RottenBurger Strasse 50 Hechingen, DE 72379 |
| Contact | Peter Kohlbecher |
| Correspondent | Robert A Poggie BioVera Inc. 65 Promenade Saint Louis Notre-dame-del-l'ile-perrot, CA J7v 7p2 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-06 |
| Decision Date | 2020-05-27 |