510(k) K090127
K090127 is an FDA 510(k) premarket notification submitted by Solana Surgical, LLC for the device "METATARSAL DECOMPRESSION IMPLANT, MODEL 100". The FDA issued a decision of Substantially Equivalent on May 1, 2009. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Solana Surgical, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2009
- Date Received
- January 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Toe, Hemi-, Phalangeal
- Device Class
- Class II
- Regulation Number
- 888.3730
- Review Panel
- OR
- Submission Type