FDA 510(k)

PIONEER CROSSFUSE II IBF/VBR SYSTEM

K-Number: K112496 · 2011-09-28

ApplicantPioneer Surgical Technology, Inc.

Decision Date2011-09-28

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PIONEER CROSSFUSE II IBF/VBR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2011-09-28 under 510(k) number K112496. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIONEER CROSSFUSE II IBF/VBR SYSTEM?

PIONEER CROSSFUSE II IBF/VBR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-28. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K112496.

When did PIONEER CROSSFUSE II IBF/VBR SYSTEM receive FDA 510(k) clearance?

PIONEER CROSSFUSE II IBF/VBR SYSTEM received FDA 510(k) clearance on 2011-09-28, under 510(k) number K112496.

Who is the listed applicant for PIONEER CROSSFUSE II IBF/VBR SYSTEM?

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

What is the FDA product code for PIONEER CROSSFUSE II IBF/VBR SYSTEM?

The FDA product code for PIONEER CROSSFUSE II IBF/VBR SYSTEM is MAX.

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Official Source

View on FDA Database →

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