510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K111065Substantially Equivalent

Stryker (R) Patient Specific Polymer Implant

Howmedica Osteonics Corp. dba Stryker Orthopeadics, Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111065 is the FDA 510(k) clearance record for STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT, a class II device, cleared for Howmedica Osteonics Corp. Dba Stryker Orthopeadics on under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable). FDA records list one 510(k) clearance for Howmedica Osteonics Corp. Dba Stryker Orthopeadics. As of , FDA records show no recalls naming K111065.

Clearance record

Decision date
Received
(87 days to decision)
Product code
GWO Plate, Cranioplasty, Preformed, Alterable
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Applicant
Howmedica Osteonics Corp. Dba Stryker Orthopeadics 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWO

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