510(k) K051603
K051603 is an FDA 510(k) premarket notification submitted by Stryker Leibinger Micro Implants for the device "STRYKER INJECTABLE CEMENT". The FDA issued a decision of Substantially Equivalent on December 30, 2005. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Stryker Leibinger Micro Implants has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2005
- Date Received
- June 15, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type