510(k) K200951
K200951 is an FDA 510(k) premarket notification submitted by Accufix Surgical, Inc. for the device "Accu-Joint Hemi Implant". The FDA issued a decision of Substantially Equivalent on December 8, 2020. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Accufix Surgical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2020
- Date Received
- April 9, 2020
- 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