The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore.
| Device ID | K181225 |
| 510k Number | K181225 |
| Device Name: | ALTAPORE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Caitlin Ziebell |
| Correspondent | Caitlin Ziebell Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-08 |
| Decision Date | 2018-08-31 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALTAPORE 87534623 not registered Live/Pending |
Baxter International Inc. 2017-07-19 |
![]() ALTAPORE 87165257 5633374 Live/Registered |
Baxter International Inc. 2016-09-08 |
![]() ALTAPORE 86064462 not registered Dead/Abandoned |
Baxter International Inc. 2013-09-13 |
![]() ALTAPORE 86008035 not registered Dead/Abandoned |
Baxter International Inc. 2013-07-11 |