Synthes Proximal Femoral Nail(Pfn) System Modification
FDA 510(k) K973240 · Synthes (Usa)
510(k) numberK973240
Submission
- Device name
- Synthes Proximal Femoral Nail(Pfn) System Modification
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- August 28, 1997
- Decision date
- November 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Synthes Proximal Femoral Nail(Pfn) System Modification cleared by the FDA?
Synthes Proximal Femoral Nail(Pfn) System Modification (K973240) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 84 days after the submission was received.
What is the product code of K973240?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.