510(k) K081608
K081608 is an FDA 510(k) premarket notification submitted by Toby Orthopaedics, LLC for the device "PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)". The FDA issued a decision of Substantially Equivalent on December 19, 2008. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Toby Orthopaedics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2008
- Date Received
- June 9, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type