510(k) K954768
K954768 is an FDA 510(k) premarket notification submitted by Biologically Oriented Prostheses for the device "BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD". The FDA issued a decision of Substantially Equivalent on January 18, 1996. 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. Biologically Oriented Prostheses has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1996
- Date Received
- October 17, 1995
- 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