Ultra-Drive 3
FDA 510(k) K031280 · Biomet, Inc.
510(k) numberK031280
Submission
- Device name
- Ultra-Drive 3
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- April 22, 2003
- Decision date
- September 22, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
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Questions and answers
When was Ultra-Drive 3 cleared by the FDA?
Ultra-Drive 3 (K031280) received a 510(k) decision of Substantially Equivalent on September 22, 2003, 153 days after the submission was received.
What is the product code of K031280?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.