510(k) K880826
K880826 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 14, 1988. The device falls under product code KYK (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite), a Class II device regulated under 21 CFR 888.3500. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1988
- Date Received
- March 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
- Device Class
- Class II
- Regulation Number
- 888.3500
- Review Panel
- OR
- Submission Type