510(k) K210228
K210228 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin IPS Preprosthetic". The FDA issued a decision of Substantially Equivalent on July 8, 2022. The device falls under product code ELE (Implant, Subperiosteal), a Class II device regulated under 21 CFR 872.3645. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2022
- Date Received
- January 28, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Subperiosteal
- Device Class
- Class II
- Regulation Number
- 872.3645
- Review Panel
- DE
- Submission Type