Vertebral Access System by Vidacare

FDA 510(k) K081713 · Vidacare Corporation

Substantially Equivalent

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

Official FDA 510(k) record

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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K013133Nordix Inc Rechargeable Battery Part Number 2116MOQ · Traditional Nordix, Inc.11/13/2001SE
K980224Alexander Manufacturing Co. Rechargeable Battery Part Number MS822MOQ · Traditional Alexander Mfg. Co.04/02/1998SE

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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.