The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos R+g Pro.
| Device ID | K142157 |
| 510k Number | K142157 |
| Device Name: | PALACOS R+G PRO |
| Classification | Bone Cement |
| Applicant | HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim, DE 61273 |
| Contact | Astrid Marx |
| Correspondent | Astrid Marx HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim, DE 61273 |
| Product Code | LOD |
| Subsequent Product Code | JDZ |
| Subsequent Product Code | KIH |
| Subsequent Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-08-06 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102136007 | K142157 | 000 |