The following data is part of a premarket notification filed by Osteosymbionics, Llc with the FDA for Osteosymbionics Patient-specific Cranial Plate.
| Device ID | K133082 |
| 510k Number | K133082 |
| Device Name: | OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | OSTEOSYMBIONICS, LLC 1768 EAST 25TH STREET SUITE 316 Cleveland, OH 44114 |
| Contact | Nicholas Wlkins |
| Correspondent | Nicholas Wlkins OSTEOSYMBIONICS, LLC 1768 EAST 25TH STREET SUITE 316 Cleveland, OH 44114 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-05-20 |
| Summary: | summary |