Depuy Ace Aim Titanium Tibial Nail
FDA 510(k) K970202 · Depuy Ace Medical Co.
510(k) numberK970202
Submission
- Device name
- Depuy Ace Aim Titanium Tibial Nail
- Applicant
- Depuy Ace Medical Co.
El Segundo, CA, US - Received
- January 21, 1997
- Decision date
- March 21, 1997
- 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 Depuy Ace Aim Titanium Tibial Nail cleared by the FDA?
Depuy Ace Aim Titanium Tibial Nail (K970202) received a 510(k) decision of Substantially Equivalent on March 21, 1997, 59 days after the submission was received.
What is the product code of K970202?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.