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FDA 510(k)

ACUTE INNOVATIONS STERNAL FIXATION SYSTEM

K-Number: K101170 · 2010-09-17

ApplicantAcute Innovations, LLC
Decision Date2010-09-17
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUTE INNOVATIONS STERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acute Innovations, LLC. It received FDA 510(k) clearance on 2010-09-17 under 510(k) number K101170. 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 ACUTE INNOVATIONS STERNAL FIXATION SYSTEM?

ACUTE INNOVATIONS STERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-17. The listed applicant is Acute Innovations, LLC. The 510(k) number is K101170.

When did ACUTE INNOVATIONS STERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

ACUTE INNOVATIONS STERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2010-09-17, under 510(k) number K101170.

Who is the listed applicant for ACUTE INNOVATIONS STERNAL FIXATION SYSTEM?

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

What is the FDA product code for ACUTE INNOVATIONS STERNAL FIXATION SYSTEM?

The FDA product code for ACUTE INNOVATIONS STERNAL FIXATION SYSTEM is KTT.

Related Clinical Trials

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Other records listing Acute Innovations, 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.

K120163ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEMK113318ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMK081588RE-ZORB PLATING SYSTEMK061206ACUTE BONE SCREW

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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