PS Omnifit Normalized Hip Stem Series
FDA 510(k) K910662 · Osteonics Corp.
510(k) numberK910662
Submission
- Device name
- PS Omnifit Normalized Hip Stem Series
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- February 14, 1991
- Decision date
- May 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- 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 |
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Questions and answers
When was PS Omnifit Normalized Hip Stem Series cleared by the FDA?
PS Omnifit Normalized Hip Stem Series (K910662) received a 510(k) decision of Substantially Equivalent on May 13, 1991, 88 days after the submission was received.
What is the product code of K910662?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.