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FDA 510(k)

HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM

K-Number: K121252 · 2012-07-25

ApplicantStryker Corp.
Decision Date2012-07-25
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K121252. 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 HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM?

HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Stryker Corp.. The 510(k) number is K121252.

When did HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2012-07-25, under 510(k) number K121252.

Who is the listed applicant for HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM?

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

What is the FDA product code for HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM?

The FDA product code for HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM is KTT.

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Other records listing Stryker 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.

K230045HipCheckK191259Stryker CrossFlow Integrated Arthroscopy PumpK182359HipCheckK122113MEMORY METAL STAPLES, EASYCLIPK122053SHAPEMATCH CUTTING GUIDEK122284HOFFMANN 3

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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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