FDA 510(k)

PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM

K-Number: K073177 · 2008-05-13

Decision Date2008-05-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K073177. 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 INTERVERTEBRAL FUSION DEVICE SYSTEM?

PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K073177.

When did PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM receive FDA 510(k) clearance?

PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM received FDA 510(k) clearance on 2008-05-13, under 510(k) number K073177.

Who is the listed applicant for PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM?

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

What is the FDA product code for PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM?

The FDA product code for PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM is MAX.

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Other records listing Pioneer Surgical Technology as applicant

K110561FORTROSS BONE VOID FILLER K101790QUANTUM SPINAL SYSTEM, QUANTUM MIS K101525PIONEER SPINOUS PROCESS FUSION PLATE K093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES K093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM K100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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Related Devices (Code: 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.