510(k) K031280
K031280 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "ULTRA-DRIVE 3". The FDA issued a decision of Substantially Equivalent on September 22, 2003. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2003
- Date Received
- April 22, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Sonic And Accessory/Attachment
- Device Class
- Class II
- Regulation Number
- 888.4580
- Review Panel
- OR
- Submission Type