Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam Fractures
FDA 510(k) K970280 · Ferguson Medical
510(k) numberK970280
Submission
- Device name
- Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam Fractures
- Applicant
- Ferguson Medical
Chico, CA, US - Received
- January 23, 1997
- Decision date
- May 22, 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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| K960421 | Sinuscan 102/SINUSPRINTLWI · Traditional | 04/16/1997SE |
Questions and answers
When was Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam Fractures cleared by the FDA?
Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam Fractures (K970280) received a 510(k) decision of Substantially Equivalent on May 22, 1997, 119 days after the submission was received.
What is the product code of K970280?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.