The following data is part of a premarket notification filed by Skeletal Kinetics, Llc. with the FDA for Osteovation Impact.
| Device ID | K162864 |
| 510k Number | K162864 |
| Device Name: | OsteoVation Impact |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | Skeletal Kinetics, LLC. 10201 Bubb Road Cupertino, CA 95014 |
| Contact | Alicia Hemphill |
| Correspondent | Alicia Hemphill Skeletal Kinetics, LLC. 10201 Bubb Road Cupertino, CA 95014 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2017-01-13 |
| Summary: | summary |