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FDA 510(k)

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT

K-Number: K090078 · 2009-05-08

ApplicantIop, Inc.
Decision Date2009-05-08
Product CodeNXM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Iop, Inc.. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K090078. The device is classified under product code NXM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT?

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Iop, Inc.. The 510(k) number is K090078.

When did KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT receive FDA 510(k) clearance?

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT received FDA 510(k) clearance on 2009-05-08, under 510(k) number K090078.

Who is the listed applicant for KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT?

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

What is the FDA product code for KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT?

The FDA product code for KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT is NXM.

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Other records listing Iop, Inc. 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.

K062252MOLTENO3K053622SURGISIS OCULAR GRAFTK010852OSMED TISSUE EXPANDERK003646SUTUREGROOVE WEIGHT SIZING SETK994289SUTUREGROOVEK972143MOA BONE / M-SPHERE

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Related Devices (Code: NXM)

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.

K053622SURGISIS OCULAR GRAFTIop, 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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