510(k) K022886
K022886 is an FDA 510(k) premarket notification submitted by Osteomed Corp. for the device "METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 2002. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Osteomed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2002
- Date Received
- August 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Toe, Constrained, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3720
- Review Panel
- OR
- Submission Type