510(k) K915548
K915548 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "IONGUARD TITANIUM MODULAR HEADS". The FDA issued a decision of Substantially Equivalent on March 10, 1992. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1992
- Date Received
- December 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type