Alphatec Femoral Trochanteric Nail (FTN) System
FDA 510(k) K042440 · Alphatec/Nexmed
510(k) numberK042440
Submission
- Device name
- Alphatec Femoral Trochanteric Nail (FTN) System
- Applicant
- Alphatec/Nexmed
Carlsbad, CA, US - Received
- September 9, 2004
- Decision date
- October 7, 2004
- 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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| K050078 | Roc Lumbar Plating SystemMNH · Traditional | 02/18/2005SE |
| K042252 | Nexflex Total Hip SystemLPH · Special | 12/06/2004SE |
| K042673 | Zodiac Polyaxial Spinal Fixation SystemKWP · Special | 10/27/2004SE |
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Questions and answers
When was Alphatec Femoral Trochanteric Nail (FTN) System cleared by the FDA?
Alphatec Femoral Trochanteric Nail (FTN) System (K042440) received a 510(k) decision of Substantially Equivalent on October 7, 2004, 28 days after the submission was received.
What is the product code of K042440?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.