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FDA 510(k)

AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE

K-Number: K020457 · 2002-09-26

ApplicantAxiamed, Inc.
Decision Date2002-09-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Axiamed, Inc.. It received FDA 510(k) clearance on 2002-09-26 under 510(k) number K020457. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE?

AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2002-09-26. The listed applicant is Axiamed, Inc.. The 510(k) number is K020457.

When did AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE receive FDA 510(k) clearance?

AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE received FDA 510(k) clearance on 2002-09-26, under 510(k) number K020457.

Who is the listed applicant for AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE?

The FDA 510(k) record lists Axiamed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE?

The FDA product code for AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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