Kinamed Ath-Ha & Ath-Ha Long Total Hip
FDA 510(k) K914843 · Kinamed, Inc.
510(k) numberK914843
Submission
- Device name
- Kinamed Ath-Ha & Ath-Ha Long Total Hip
- Applicant
- Kinamed, Inc.
Washington, DC, US - Received
- October 28, 1991
- Decision date
- February 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Kinamed Ath-Ha & Ath-Ha Long Total Hip cleared by the FDA?
Kinamed Ath-Ha & Ath-Ha Long Total Hip (K914843) received a 510(k) decision of Substantially Equivalent on February 3, 1992, 98 days after the submission was received.
What is the product code of K914843?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.