510(k) K885069
K885069 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)". The FDA issued a decision of SN on September 1, 1989. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- September 1, 1989
- Date Received
- December 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type