510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122353Substantially Equivalent

Crainfix 2 Titanium Clamp System

Aesculap Inc, Center Valley PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122353 is the FDA 510(k) clearance record for CRAINFIX 2 TITANIUM CLAMP SYSTEM, a class II device, cleared for Aesculap, Inc. on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K122353.

Clearance record

Decision date
Received
(27 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXN

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