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FDA 510(k)

TARGON FN SYSTEM

K-Number: K102057 · 2010-12-21

ApplicantAesculap Implant Systems, LLC
Decision Date2010-12-21
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TARGON FN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2010-12-21 under 510(k) number K102057. 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 TARGON FN SYSTEM?

TARGON FN SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K102057.

When did TARGON FN SYSTEM receive FDA 510(k) clearance?

TARGON FN SYSTEM received FDA 510(k) clearance on 2010-12-21, under 510(k) number K102057.

Who is the listed applicant for TARGON FN SYSTEM?

The FDA 510(k) record lists Aesculap Implant Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TARGON FN SYSTEM?

The FDA product code for TARGON FN SYSTEM is KTT.

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Other records listing Aesculap Implant Systems, LLC 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.

K213871Ennovate Cervical Spinal and Occiput SystemK210963ENNOVATE Spinal SystemK180433ENNOVATE®K162134ENNOVATE Spinal SystemK153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsK153396Aesculap OrthoPilot Next Generation

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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 GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.

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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