510(k) K944752
K944752 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "ORTHOMET RESURFACING FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on December 28, 1994. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Orthomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1994
- Date Received
- September 26, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Femoral, Resurfacing
- Device Class
- Class II
- Regulation Number
- 888.3400
- Review Panel
- OR
- Submission Type