Kinamed Profix System
FDA 510(k) K964362 · Kinamed, Inc.
510(k) numberK964362
Submission
- Device name
- Kinamed Profix System
- Applicant
- Kinamed, Inc.
Newbury Park, CA, US - Received
- November 1, 1996
- Decision date
- January 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Kinamed Profix System cleared by the FDA?
Kinamed Profix System (K964362) received a 510(k) decision of Substantially Equivalent on January 16, 1997, 76 days after the submission was received.
What is the product code of K964362?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.