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FDA 510(k)

K2M Growing Spine System

K-Number: K161028 · 2016-07-22

ApplicantK2m, Inc.
Decision Date2016-07-22
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K2M Growing Spine System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161028. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K2M Growing Spine System?

K2M Growing Spine System is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is K2m, Inc.. The 510(k) number is K161028.

When did K2M Growing Spine System receive FDA 510(k) clearance?

K2M Growing Spine System received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161028.

Who is the listed applicant for K2M Growing Spine System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Growing Spine System?

The FDA product code for K2M Growing Spine System is PGM.

Other records listing K2m, Inc. as applicant

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Related Devices (Code: PGM)

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.

K251961SDS Growing RodBAAT Medical Products B.V.K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.K213196MARVEL™ Growing RodsGlobus Medical, Inc.K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics CorporationK191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemMedos International SARLK181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, 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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