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FDA 510(k)

PIONEER LABORATORIES BONE SCREW

K-Number: K940690 · 1994-11-22

ApplicantPioneer Surgical Technology
Decision Date1994-11-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PIONEER LABORATORIES BONE SCREW 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 1994-11-22 under 510(k) number K940690. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PIONEER LABORATORIES BONE SCREW?

PIONEER LABORATORIES BONE SCREW is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K940690.

When did PIONEER LABORATORIES BONE SCREW receive FDA 510(k) clearance?

PIONEER LABORATORIES BONE SCREW received FDA 510(k) clearance on 1994-11-22, under 510(k) number K940690.

Who is the listed applicant for PIONEER LABORATORIES BONE SCREW?

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 LABORATORIES BONE SCREW?

The FDA product code for PIONEER LABORATORIES BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Pioneer Surgical Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110561FORTROSS BONE VOID FILLERK101790QUANTUM SPINAL SYSTEM, QUANTUM MISK101525PIONEER SPINOUS PROCESS FUSION PLATEK093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIESK093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEMK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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Related Devices (Code: HWC)

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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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