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FDA 510(k)

Striate+™

K-Number: K201241 · 2021-01-11

ApplicantOrthocell, Ltd.
Decision Date2021-01-11
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Striate+™ is the device name listed in this FDA 510(k) record. The listed applicant is Orthocell, Ltd.. It received FDA 510(k) clearance on 2021-01-11 under 510(k) 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. The listed applicant is Orthocell, Ltd.. The 510(k) number is K201241.

When did Striate+™ receive FDA 510(k) clearance?

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

Who is the listed applicant for Striate+™?

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

What is the FDA product code for Striate+™?

The FDA product code for Striate+™ is NPL.

Other records listing Orthocell, Ltd. 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.

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)

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.

K242817Jason membraneBotiss Biomaterials GmbHK250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AGK250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AGK233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, 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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