510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K123633Substantially Equivalent

Trs Cranial Bone Void Filler(trs C-Bvf)

Tissue Regeneration Systems, Inc., Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123633 is the FDA 510(k) clearance record for TRS CRANIAL BONE VOID FILLER(TRS C-BVF), a class II device, cleared for Tissue Regeneration Systems, Inc. on under FDA product code GXR (Cover, Burr Hole). FDA records list one 510(k) clearance for Tissue Regeneration Systems, Inc. As of , FDA records show no recalls naming K123633.

Clearance record

Decision date
Received
(266 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Tissue Regeneration Systems, Inc. 5400 Carillon Pt., Kirkland WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXR

Trailing 12 months
1 clearance under product code GXR in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260