Biomet Femoral Locking Nail System
FDA 510(k) K072161 · Biomet Manufacturing Corp
510(k) numberK072161
Submission
- Device name
- Biomet Femoral Locking Nail System
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- August 6, 2007
- Decision date
- September 20, 2007
- 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 Biomet Femoral Locking Nail System cleared by the FDA?
Biomet Femoral Locking Nail System (K072161) received a 510(k) decision of Substantially Equivalent on September 20, 2007, 45 days after the submission was received.
What is the product code of K072161?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.