510(k) K080842
K080842 is an FDA 510(k) premarket notification submitted by Omni Life Science, Inc. for the device "APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]". The FDA issued a decision of Substantially Equivalent on May 23, 2008. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Omni Life Science, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2008
- Date Received
- March 25, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type