The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Hydroset Xt.
| Device ID | K161447 |
| 510k Number | K161447 |
| Device Name: | HydroSet XT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Tina Mornak |
| Correspondent | Lia Gonzalez STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-25 |
| Decision Date | 2016-10-06 |
| Summary: | summary |