510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971408Substantially Equivalent

Sevrain Cranial Clamp (Scc-200 Series)

Ikonos Corp., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971408 is the FDA 510(k) clearance record for SEVRAIN CRANIAL CLAMP (SCC-200 SERIES), a class II device, cleared for Ikonos Corp. on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list 3 510(k) clearances for Ikonos Corp., from to . As of , FDA records show no recalls naming K971408.

Clearance record

Decision date
Received
(391 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Ikonos Corp. 320 SW 6th. Ave., 2nd. Floor, Portland OR
510(k) summary
Statement
Third party review
No

Clearances, product code GXN

Trailing 12 months
6 clearances under product code GXN in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GXN, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260