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FDA 510(k)

WILTSE SYSTEM

K-Number: K992012 · 2000-02-04

ApplicantAdvanced Spine Fixation Systems, Inc.
Decision Date2000-02-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WILTSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Spine Fixation Systems, Inc.. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K992012. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILTSE SYSTEM?

WILTSE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Advanced Spine Fixation Systems, Inc.. The 510(k) number is K992012.

When did WILTSE SYSTEM receive FDA 510(k) clearance?

WILTSE SYSTEM received FDA 510(k) clearance on 2000-02-04, under 510(k) number K992012.

Who is the listed applicant for WILTSE SYSTEM?

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

What is the FDA product code for WILTSE SYSTEM?

The FDA product code for WILTSE SYSTEM is KWQ.

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Other records listing Advanced Spine Fixation Systems, Inc. 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.

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Related Devices (Code: KWQ)

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.

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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.

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