510(k) K903286
K903286 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION". The FDA issued a decision of SN on October 12, 1990. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Techmedica, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- October 12, 1990
- Date Received
- July 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3520
- Review Panel
- OR
- Submission Type