510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161052Substantially Equivalent

OsteoFab Patient Specific Facial Device

Oxford Performance Materials, Inc., South Windsor CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161052 is the FDA 510(k) clearance record for OsteoFab Patient Specific Facial Device, a class II device, cleared for Oxford Performance Materials, Inc. on under FDA product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction). FDA records list 6 510(k) clearances for Oxford Performance Materials, Inc., from to . As of , FDA records show no recalls naming K161052.

Clearance record

Decision date
Received
(97 days to decision)
Product code
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Oxford Performance Materials, Inc. 30 S Satellite Rd., South Windsor CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KKY

Trailing 12 months

FDA records hold no clearances under product code KKY in the trailing twelve months.

FDA records show no clearances under product code KKY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KKY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260