Modular VS-22 Cemented Femoral Hip System
FDA 510(k) K941534 · 3M Health Care, Ltd.
510(k) numberK941534
Submission
- Device name
- Modular VS-22 Cemented Femoral Hip System
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- March 30, 1994
- Decision date
- March 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Modular VS-22 Cemented Femoral Hip System cleared by the FDA?
Modular VS-22 Cemented Femoral Hip System (K941534) received a 510(k) decision of Substantially Equivalent on March 6, 1995, 341 days after the submission was received.
What is the product code of K941534?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.