OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
FDA 510(k) clearance K111069 · decided 2011-09-22
Clearance details
- K-number
- K111069
- Device name
- OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
- Applicant
- Osteosymbionics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-04-18
- Decision date
- 2011-09-22
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- MNF
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osteosymbionics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDPOR PTERIONAL SURGICAL IMPLANT (K002586) | Porex Surgical Products Group | 2000-11-17 |
Recalls involving this device
No recalls on record reference this clearance.