Fixion Unipolar Modular Hemi-Hip System (Fixion MH)
FDA 510(k) K030972 · Disc-O-Tech Medical Technologies, Ltd.
510(k) numberK030972
Submission
- Device name
- Fixion Unipolar Modular Hemi-Hip System (Fixion MH)
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
Herzelia, IL - Received
- March 28, 2003
- Decision date
- May 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Fixion Unipolar Modular Hemi-Hip System (Fixion MH) cleared by the FDA?
Fixion Unipolar Modular Hemi-Hip System (Fixion MH) (K030972) received a 510(k) decision of Substantially Equivalent on May 30, 2003, 63 days after the submission was received.
What is the product code of K030972?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.