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FDA 510(k)

MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

K-Number: K030372 · 2003-03-06

ApplicantEbi, L.P.
Decision Date2003-03-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2003-03-06 under 510(k) number K030372. 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 EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM?

MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-06. The listed applicant is Ebi, L.P.. The 510(k) number is K030372.

When did MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM received FDA 510(k) clearance on 2003-03-06, under 510(k) number K030372.

Who is the listed applicant for MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM?

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

What is the FDA product code for MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM?

The FDA product code for MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM is KTT.

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Other records listing Ebi, L.P. 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.

K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100220POLARIS SPINAL SYSTEMK093880PEANUT GROWTH CONTROL PLATING SYSTEMK092574ESL SPINAL SYSTEMK093057BIOMET VISION FOOTRING SYSTEMK092336C-THRU SPINAL 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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