510(k) K221968
K221968 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "StageOne Shoulder Cement Spacer Molds". The FDA issued a decision of Substantially Equivalent on September 15, 2022. The device falls under product code MBB (Bone Cement, Antibiotic), a Class II device regulated under 21 CFR 888.3027. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2022
- Date Received
- July 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Cement, Antibiotic
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type