FDA 510(k)

Striate+

K-Number: K201241 · 2021-01-11

Decision Date2021-01-11

Product CodeNPL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Striate+ is a medical device manufactured by Orthocell, Ltd.. It received FDA 510(k) clearance on 2021-01-11 under approval number K201241. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Striate+?

Striate+ is a medical device that received FDA 510(k) clearance on 2021-01-11. It is manufactured by Orthocell, Ltd.. The 510(k) number is K201241.

When was Striate+ approved by the FDA?

Striate+ received FDA 510(k) clearance on 2021-01-11, under approval number K201241.

What company makes Striate+?

Striate+ is manufactured by Orthocell, Ltd..

What is the FDA product code for Striate+?

The FDA product code for Striate+ is NPL.

Other Devices by Orthocell, Ltd.

K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

Related Devices (Code: NPL)

K160281OSSIX PLUSDatum Dental, Ltd. K153549OSSIX VOLUMAXDatum Dental, Ltd. K160474DSM Biomedical Porcine Pericardium Dental MembraneKensey Nash Corporation Dba Dsm Biomedical K171050Geistlich Fibro-GideGeistlich Pharma AG K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG K161762DynaMatrix/Dynamatrix PlusCook Biotech Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.