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FDA 510(k)

Stablyx CMC Arthroplasty Implant System

K-Number: K180744 · 2018-04-11

ApplicantSkeletal Dynamics, LLC
Decision Date2018-04-11
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stablyx CMC Arthroplasty Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K180744. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stablyx CMC Arthroplasty Implant System?

Stablyx CMC Arthroplasty Implant System is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K180744.

When did Stablyx CMC Arthroplasty Implant System receive FDA 510(k) clearance?

Stablyx CMC Arthroplasty Implant System received FDA 510(k) clearance on 2018-04-11, under 510(k) number K180744.

Who is the listed applicant for Stablyx CMC Arthroplasty Implant System?

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

What is the FDA product code for Stablyx CMC Arthroplasty Implant System?

The FDA product code for Stablyx CMC Arthroplasty Implant System is KYI.

Related Clinical Trials

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.

NCT06467760Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx ImplantTERMINATED

Other records listing Skeletal Dynamics, 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.

K261770Suture Button Repair SystemK254288Clavicle Fixation SystemK252949Geminus Volar Distal Radius Plating SystemK242436Proximal Humerus Fixation SystemK243381Total Wrist Arthroplasty System (TWA)K241815Protean Fragment Plating System

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Related Devices (Code: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC

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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