Affixus Tibial Nailing System
FDA 510(k) K150867 · Biomet, Inc.
510(k) numberK150867
Submission
- Device name
- Affixus Tibial Nailing System
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- April 1, 2015
- Decision date
- June 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Affixus Tibial Nailing System cleared by the FDA?
Affixus Tibial Nailing System (K150867) received a 510(k) decision of Substantially Equivalent on June 10, 2015, 70 days after the submission was received.
What is the product code of K150867?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.