510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K973789Substantially Equivalent

Norian Cranial Repair System (Crs)bone Cement- 5Cc Kit, Norian Cranial Repair System (Crs) Bone Cement- 10Cc

Norian Corp., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973789 is the FDA 510(k) clearance record for NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC, a class II device, cleared for Norian Corp. on under FDA product code GXP (Methyl Methacrylate For Cranioplasty). FDA records list 3 510(k) clearances for Norian Corp., from to . As of , FDA records show no recalls naming K973789.

Clearance record

Decision date
Received
(224 days to decision)
Product code
GXP Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Norian Corp. 10260 Bubb Rd., Cupertino CA
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