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FDA 510(k)

DANEK WRIST FIXATOR

K-Number: K891066 · 1989-08-28

ApplicantDanek Medical, Inc.
Decision Date1989-08-28
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DANEK WRIST FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K891066. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANEK WRIST FIXATOR?

DANEK WRIST FIXATOR is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Danek Medical, Inc.. The 510(k) number is K891066.

When did DANEK WRIST FIXATOR receive FDA 510(k) clearance?

DANEK WRIST FIXATOR received FDA 510(k) clearance on 1989-08-28, under 510(k) number K891066.

Who is the listed applicant for DANEK WRIST FIXATOR?

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

What is the FDA product code for DANEK WRIST FIXATOR?

The FDA product code for DANEK WRIST FIXATOR is KTT.

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Other records listing Danek Medical, Inc. as applicant

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K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118K993810CD HORIZON SPINAL SYSTEMK993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMK991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORK990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMK982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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