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FDA 510(k)

BONE PLATE; BONE SCREW

K-Number: K110926 · 2011-12-08

ApplicantBiomaterials Korea, Inc.
Decision Date2011-12-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE PLATE; BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biomaterials Korea, Inc.. It received FDA 510(k) clearance on 2011-12-08 under 510(k) number K110926. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE PLATE; BONE SCREW?

BONE PLATE; BONE SCREW is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Biomaterials Korea, Inc.. The 510(k) number is K110926.

When did BONE PLATE; BONE SCREW receive FDA 510(k) clearance?

BONE PLATE; BONE SCREW received FDA 510(k) clearance on 2011-12-08, under 510(k) number K110926.

Who is the listed applicant for BONE PLATE; BONE SCREW?

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

What is the FDA product code for BONE PLATE; BONE SCREW?

The FDA product code for BONE PLATE; BONE SCREW is JEY.

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Other records listing Biomaterials Korea, Inc. as applicant

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Related Devices (Code: JEY)

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Official Source

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