510(k) K984585
K984585 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE". The FDA issued a decision of Substantially Equivalent on February 24, 1999. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Osteonics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1999
- Date Received
- December 24, 1998
- 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