Osteo Austin Moore Endoprosthesis System
FDA 510(k) K974807 · Osteonics Corp.
510(k) numberK974807
Submission
- Device name
- Osteo Austin Moore Endoprosthesis System
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- December 23, 1997
- Decision date
- March 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- 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 |
| K984302 | Osteonics Spinal System Cylindrical Bone ScrewsMNH · Special | 12/18/1998SE |
| 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 Austin Moore Endoprosthesis System cleared by the FDA?
Osteo Austin Moore Endoprosthesis System (K974807) received a 510(k) decision of Substantially Equivalent on March 16, 1998, 83 days after the submission was received.
What is the product code of K974807?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.