510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883576Substantially Equivalent

Horizon Orthopedic Pin Protector

Horizon Medical, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883576 is the FDA 510(k) clearance record for HORIZON ORTHOPEDIC PIN PROTECTOR, a class II device, cleared for Horizon Medical, Inc. on under FDA product code LYT (Fixation Accessory). FDA records list 3 510(k) clearances for Horizon Medical, Inc., from to . As of , FDA records show no recalls naming K883576.

Clearance record

Decision date
Received
(39 days to decision)
Product code
LYT Fixation Accessory
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Horizon Medical, Inc. 324 State St., St. Paul MN
Third party review
No

Clearances, product code LYT

Trailing 12 months

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

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