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FDA 510(k)

TRS CRANIAL BONE VOID FILLER(TRS C-BVF)

K-Number: K123633 · 2013-08-16

ApplicantTissue Regeneration Systems, Inc.
Decision Date2013-08-16
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRS CRANIAL BONE VOID FILLER(TRS C-BVF) is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Systems, Inc.. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K123633. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRS CRANIAL BONE VOID FILLER(TRS C-BVF)?

TRS CRANIAL BONE VOID FILLER(TRS C-BVF) is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Tissue Regeneration Systems, Inc.. The 510(k) number is K123633.

When did TRS CRANIAL BONE VOID FILLER(TRS C-BVF) receive FDA 510(k) clearance?

TRS CRANIAL BONE VOID FILLER(TRS C-BVF) received FDA 510(k) clearance on 2013-08-16, under 510(k) number K123633.

Who is the listed applicant for TRS CRANIAL BONE VOID FILLER(TRS C-BVF)?

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

What is the FDA product code for TRS CRANIAL BONE VOID FILLER(TRS C-BVF)?

The FDA product code for TRS CRANIAL BONE VOID FILLER(TRS C-BVF) is GXR.

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Related Devices (Code: GXR)

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.

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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.

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