The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Osteopal Plus.
| Device ID | K153737 |
| 510k Number | K153737 |
| Device Name: | OSTEOPAL Plus |
| Classification | Bone Cement |
| Applicant | HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim, DE 61273 |
| Contact | Astrid Marx |
| Correspondent | Gordon Macfarlane ICON Plc 62 Forest Street Marlborough, MA 01752 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102132603 | K153737 | 000 |