510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983009Substantially Equivalent

Bsm- Bone Substitute Material

Etex Corp., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983009 is the FDA 510(k) clearance record for BSM- BONE SUBSTITUTE MATERIAL, a class II device, cleared for Etex Corp. on under FDA product code GXP (Methyl Methacrylate For Cranioplasty). FDA records list 24 510(k) clearances for Etex Corp., from to . As of , FDA records show no recalls naming K983009.

Clearance record

Decision date
Received
(89 days to decision)
Product code
GXP Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Etex Corp. 350 Massachusettes Ave., 4flr, Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code GXP

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