Vented Cement Restrictor
FDA 510(k) K022729 · Amedica Corp.
510(k) numberK022729
Submission
- Device name
- Vented Cement Restrictor
- Applicant
- Amedica Corp.
Salt Lake City, UT, US - Received
- August 16, 2002
- Decision date
- November 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
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Questions and answers
When was Vented Cement Restrictor cleared by the FDA?
Vented Cement Restrictor (K022729) received a 510(k) decision of Substantially Equivalent on November 14, 2002, 90 days after the submission was received.
What is the product code of K022729?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.