The following data is part of a premarket notification filed by Osteosymbionics, Llc with the FDA for Osteosymbionics Peek Cranial Implant.
| Device ID | K121102 |
| 510k Number | K121102 |
| Device Name: | OSTEOSYMBIONICS PEEK CRANIAL IMPLANT |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | OSTEOSYMBIONICS, LLC P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan OSTEOSYMBIONICS, LLC P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-11 |
| Decision Date | 2012-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866453000123 | K121102 | 000 |