Vertebral Access System by Vidacare
FDA 510(k) K081713 · Vidacare Corporation
510(k) numberK081713
Submission
- Device name
- Vertebral Access System by Vidacare
- Applicant
- Vidacare Corporation
Irvine, CA, US - Received
- June 17, 2008
- Decision date
- November 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOQ – Battery, Replacement, Rechargeable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MOQ
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Questions and answers
When was Vertebral Access System by Vidacare cleared by the FDA?
Vertebral Access System by Vidacare (K081713) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 157 days after the submission was received.
What is the product code of K081713?
The FDA product code is MOQ – Battery, Replacement, Rechargeable, a Class I (low risk) device regulated under 21 CFR 878.4820.