510(k) K883727
K883727 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "BUCKET PROSTHESIS PORP". The FDA issued a decision of Substantially Equivalent on January 13, 1989. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1989
- Date Received
- August 31, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Partial Ossicular Replacement
- Device Class
- Class II
- Regulation Number
- 874.3450
- Review Panel
- EN
- Submission Type