510(k) K111069
- Device
- OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
- Applicant
- OSTEOSYMBIONICS, LLC
- 510(k) number
- K111069
- Product code
- MNF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-22
- Date received
- 2011-04-18
- Regulation
- 878.3550
- Classification name
- Implant, Temporal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELAINE DUNCAN
- Address
- P.O. Box 560 Stillwater MN US 55082 55082
FDA Registration Numbers#
- 1018470
- 8010177
Source Documents#
Other 510(k) Records For Product Code MNF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002586 | MEDPOR PTERIONAL SURGICAL IMPLANT | Porex Surgical Products Group | 2000-11-17 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases