510(k) K926216
K926216 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "BONE CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1994
- Date Received
- December 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Cement Restrictor
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type