The following data is part of a premarket notification filed by 3d Systems, Inc. with the FDA for Vsp Cranial System.
| Device ID | K151285 |
| 510k Number | K151285 |
| Device Name: | VSP Cranial System |
| Classification | Cranial Surgical Planning And Instrument Guides |
| Applicant | 3D Systems, Inc. 17301 West Colfax Avenue, Suite 300 Golden, CO 80401 |
| Contact | Kim Torluemke |
| Correspondent | Kim Torluemke 3D Systems, Inc. 17301 West Colfax Avenue, Suite 300 Golden, CO 80401 |
| Product Code | PPT |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-14 |
| Decision Date | 2016-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816847021449 | K151285 | 000 |
| 00816847021432 | K151285 | 000 |
| 00816847021425 | K151285 | 000 |