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FDA 510(k)

OrthoGold 100

K-Number: K182682 · 2018-12-21

ApplicantTissue Regeneration Technologies
Decision Date2018-12-21
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OrthoGold 100 is a medical device manufactured by Tissue Regeneration Technologies. It received FDA 510(k) clearance on 2018-12-21 under approval number K182682. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoGold 100?

OrthoGold 100 is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Tissue Regeneration Technologies. The 510(k) number is K182682.

When was OrthoGold 100 approved by the FDA?

OrthoGold 100 received FDA 510(k) clearance on 2018-12-21, under approval number K182682.

What company makes OrthoGold 100?

OrthoGold 100 is manufactured by Tissue Regeneration Technologies.

What is the FDA product code for OrthoGold 100?

The FDA product code for OrthoGold 100 is ISA.

Other Devices by Tissue Regeneration Technologies

K191961OrthoGold

Related Devices (Code: ISA)

K173692D-Actor 200 Vibration Massage SystemStorz Medical AG K210451OrthoGold 100Tissue Regeneration Technologies, LLC K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt K220538DolorClast RadialE.M.S Electro Medical Systems S.A K221865BTL-094BTL Industries, Inc. K210166Omnispec ED1000Medispec, Ltd.

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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