The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore.
| Device ID | K192363 | 
| 510k Number | K192363 | 
| Device Name: | Altapore | 
| Classification | Filler, Bone Void, Calcium Compound | 
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 | 
| Contact | Phillip Romei | 
| Correspondent | Phillip Romei 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 | 2019-08-30 | 
| Decision Date | 2020-01-09 | 
| 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 |