510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033868Substantially Equivalent

Synthes (USA) Patient Specific Cranial/craniofacial Implants

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033868 is the FDA 510(k) clearance record for SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS, a class II device, cleared for Synthes (Usa) on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K033868.

Clearance record

Decision date
Received
(192 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli 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