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FDA 510(k)

MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES

K-Number: K032058 · 2003-07-30

ApplicantAlliance Medical Corp.
Decision Date2003-07-30
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical Corp.. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K032058. 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 MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES?

MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Alliance Medical Corp.. The 510(k) number is K032058.

When did MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES receive FDA 510(k) clearance?

MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES received FDA 510(k) clearance on 2003-07-30, under 510(k) number K032058.

Who is the listed applicant for MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES?

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

What is the FDA product code for MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES?

The FDA product code for MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES is KTT.

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Other records listing Alliance Medical Corp. 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.

K060648REPROCESSED PHACOEMULSIFICATION TIPSK061045REPROCESSED ELECTROPHYSIOLOGY CATHETERSK060049REPROCESSED COMPRESSION SLEEVESK060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVESK053316REPROCESSED COMPRESSION SLEEVESK052918REPROCESSED EXTERNAL FIXATION DEVICES

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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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