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FDA 510(k)

DOGBONE ACFS

K-Number: K994383 · 2000-02-04

ApplicantTheken Surgical
Decision Date2000-02-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DOGBONE ACFS is the device name listed in this FDA 510(k) record. The listed applicant is Theken Surgical. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K994383. 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 DOGBONE ACFS?

DOGBONE ACFS is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Theken Surgical. The 510(k) number is K994383.

When did DOGBONE ACFS receive FDA 510(k) clearance?

DOGBONE ACFS received FDA 510(k) clearance on 2000-02-04, under 510(k) number K994383.

Who is the listed applicant for DOGBONE ACFS?

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

What is the FDA product code for DOGBONE ACFS?

The FDA product code for DOGBONE ACFS is KWQ.

Related Clinical Trials

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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Other records listing Theken Surgical 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.

K041592CORAL SPINAL SYSTEMK994382NONLINEAR TAPER LAG SCREW

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

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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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