Dynasty Biofoam Shell
FDA 510(k) K122382 · Wrightmedicaltechnologyinc
510(k) numberK122382
Submission
- Device name
- Dynasty Biofoam Shell
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- August 6, 2012
- Decision date
- October 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Dynasty Biofoam Shell cleared by the FDA?
Dynasty Biofoam Shell (K122382) received a 510(k) decision of Substantially Equivalent on October 22, 2012, 77 days after the submission was received.
What is the product code of K122382?
The FDA product code is MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, a Class II (moderate risk) device regulated under 21 CFR 888.3358.