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FDA 510(k)

FIXEL EXTERNAL FIXATION DEVICE

K-Number: K923032 · 1993-10-04

ApplicantAmp, Inc.
Decision Date1993-10-04
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXEL EXTERNAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Amp, Inc.. It received FDA 510(k) clearance on 1993-10-04 under 510(k) number K923032. 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 FIXEL EXTERNAL FIXATION DEVICE?

FIXEL EXTERNAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1993-10-04. The listed applicant is Amp, Inc.. The 510(k) number is K923032.

When did FIXEL EXTERNAL FIXATION DEVICE receive FDA 510(k) clearance?

FIXEL EXTERNAL FIXATION DEVICE received FDA 510(k) clearance on 1993-10-04, under 510(k) number K923032.

Who is the listed applicant for FIXEL EXTERNAL FIXATION DEVICE?

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

What is the FDA product code for FIXEL EXTERNAL FIXATION DEVICE?

The FDA product code for FIXEL EXTERNAL FIXATION DEVICE is KTT.

Related Clinical Trials

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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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