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FDA 510(k)

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

K-Number: K211313 · 2021-05-25

ApplicantSynthes (USA) Products, LLC
Decision Date2021-05-25
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K211313. 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 MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K211313.

When did MAXFRAME Multi-Axial Correction System (aka MAXFRAME) receive FDA 510(k) clearance?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) received FDA 510(k) clearance on 2021-05-25, under 510(k) number K211313.

Who is the listed applicant for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

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

What is the FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

The FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is KTT.

Other records listing Synthes (USA) Products, 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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemK212943SyntheCel Dura RepairK210408DePuy Synthes Variable Angle Locking Patella Plating SystemK210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemK201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mmK192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

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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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