The following data is part of a premarket notification filed by Osteosymbionics, Llc with the FDA for Osteosymbionics, St Temporalis Implant.
| Device ID | K111069 |
| 510k Number | K111069 |
| Device Name: | OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT |
| Classification | Implant, Temporal |
| 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 | MNF |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866453000147 | K111069 | 000 |
| 00866453000130 | K111069 | 000 |