510(k) K190181
K190181 is an FDA 510(k) premarket notification submitted by LinkBio Corp. for the device "Instruments for LINK MEGASYSTEM-C Family". The FDA issued a decision of Substantially Equivalent on October 25, 2019. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. LinkBio Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2019
- Date Received
- February 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3510
- Review Panel
- OR
- Submission Type