510(k) K203634
K203634 is an FDA 510(k) premarket notification submitted by BioPoly, LLC for the device "BioPoly Great Toe Hemiarthroplasty Implant". The FDA issued a decision of Substantially Equivalent on February 2, 2021. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. BioPoly, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2021
- Date Received
- December 11, 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