Cannulated Femoral Nail
FDA 510(k) K954856 · Synthes (Usa)
510(k) numberK954856
Submission
- Device name
- Cannulated Femoral Nail
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- October 23, 1995
- Decision date
- March 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDN – Implant, Fixation Device, Spinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K897141 | Slot Staples and Adaptor for Zielke Spinal FixatioJDN · Traditional | Stuart | 06/21/1990SN |
| K894184 | Biedermann Motech Universal Spinal SystemJDN · Traditional | Biedermann Motech GmbH | 04/25/1990SN |
| K873977 | New C-D System for Spinal SurgeryJDN · Traditional | Sofamor Co. | 12/07/1987SN |
| K872715 | Universal Instrumentation(Cd) for Spinal SurgeryJDN · Traditional | Roseburg SA | 12/07/1987SN |
| K760649 | Total Spinal CorrectionJDN · Traditional | Depuy, Inc. | 10/05/1976SE |
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Questions and answers
When was Cannulated Femoral Nail cleared by the FDA?
Cannulated Femoral Nail (K954856) received a 510(k) decision of Substantially Equivalent on March 8, 1996, 137 days after the submission was received.
What is the product code of K954856?
The FDA product code is JDN – Implant, Fixation Device, Spinal, a Class II (moderate risk) device regulated under 21 CFR 888.3060.