510(k) K133285
K133285 is an FDA 510(k) premarket notification submitted by Stryker for the device "STRYKER TEMPORARY CONDYLAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 9, 2014. The device falls under product code NEI (Prosthesis, Condyle, Mandibular, Temporary), a Class II device regulated under 21 CFR 872.4770. Stryker has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2014
- Date Received
- October 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Condyle, Mandibular, Temporary
- Device Class
- Class II
- Regulation Number
- 872.4770
- Review Panel
- DE
- Submission Type