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FDA 510(k)

REPROCESSED EXTERNAL FIXATION DEVICE

K-Number: K083636 · 2009-03-02

ApplicantSterilmed, Inc.
Decision Date2009-03-02
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPROCESSED EXTERNAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2009-03-02 under 510(k) number K083636. 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 REPROCESSED EXTERNAL FIXATION DEVICE?

REPROCESSED EXTERNAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2009-03-02. The listed applicant is Sterilmed, Inc.. The 510(k) number is K083636.

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

REPROCESSED EXTERNAL FIXATION DEVICE received FDA 510(k) clearance on 2009-03-02, under 510(k) number K083636.

Who is the listed applicant for REPROCESSED EXTERNAL FIXATION DEVICE?

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

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

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

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Other records listing Sterilmed, Inc. 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.

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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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