The following data is part of a premarket notification filed by Osteosymbionics, Llc with the FDA for Osteosymbionics Patient Specific Cranial Implant.
| Device ID | K072601 |
| 510k Number | K072601 |
| Device Name: | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | OSTEOSYMBIONICS, LLC 1768 EAST 25TH STREET Cleveland, OH 44114 |
| Contact | Cynthia M Brogan |
| Correspondent | Cynthia M Brogan OSTEOSYMBIONICS, LLC 1768 EAST 25TH STREET Cleveland, OH 44114 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2007-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866453000109 | K072601 | 000 |