510(k) K924050
K924050 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Orthomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1993
- Date Received
- August 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type