510(k) K981238
K981238 is an FDA 510(k) premarket notification submitted by Whiteside Biomechanics, Inc. for the device "BIPOLAR FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on August 21, 1998. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Whiteside Biomechanics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1998
- Date Received
- April 3, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3390
- Review Panel
- OR
- Submission Type