510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833114Substantially Equivalent

Oxford Mark 2 External Fixator

Johnson & Johnson Professionals, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833114 is the FDA 510(k) clearance record for OXFORD MARK 2 EXTERNAL FIXATOR, a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code JEC (Component, Traction, Invasive). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K833114.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Johnson & Johnson Professionals, Inc. 325 Paramount Dr., Raynham MA
Third party review
No

Clearances, product code JEC

Trailing 12 months

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

FDA records show no clearances under product code JEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEC, 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