Osteo Dynatroc Proximal Femoral Nail
FDA 510(k) K983339 · Osteonics Corp.
510(k) numberK983339
Submission
- Device name
- Osteo Dynatroc Proximal Femoral Nail
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- September 23, 1998
- Decision date
- October 27, 1998
- 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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| K990203 | Osteonics Primary Secur-Fit Plus Hip StemsMEH · Special | 02/18/1999SE |
| K990158 | Osteonics Combination Screw Ring/BlockerMNI · Special | 02/01/1999SE |
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| K984353 | Osteo 9MM Ic Tibial NailHSB · Special | 12/16/1998SE |
| K983502 | Osteonics Secur-Fit Ad Generation II Acetabular Component SystemLPH · Traditional | 12/16/1998SE |
Questions and answers
When was Osteo Dynatroc Proximal Femoral Nail cleared by the FDA?
Osteo Dynatroc Proximal Femoral Nail (K983339) received a 510(k) decision of Substantially Equivalent on October 27, 1998, 34 days after the submission was received.
What is the product code of K983339?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.