The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore Shape.
| Device ID | K200640 |
| 510k Number | K200640 |
| Device Name: | ALTAPORE SHAPE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Contact | Phillip Romei |
| Correspondent | Phillip Romei Baxter Healthcare Corporation 25212 W. Illinois Route 120 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 | 2020-03-11 |
| Decision Date | 2020-05-08 |