The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos Mv Pro.
| Device ID | K213812 |
| 510k Number | K213812 |
| Device Name: | PALACOS MV Pro |
| Classification | Bone Cement |
| Applicant | Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim, DE 61273 |
| Contact | Ljuba Jaeckel |
| Correspondent | Ljuba Jaeckel Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim, DE 61273 |
| Product Code | LOD |
| Subsequent Product Code | JDZ |
| Subsequent Product Code | KIH |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-07 |
| Decision Date | 2022-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102135376 | K213812 | 000 |
| 04260102135338 | K213812 | 000 |