510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K992348Substantially Equivalent

Synthes Spiral Blade for Humeral Nail (Sbhn)

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

K992348 is the FDA 510(k) clearance record for SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN), a class II device, cleared for Synthes (Usa) on under FDA product code JDS (Nail, Fixation, Bone). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 2 recalls naming K992348.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JDS Nail, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) P.O. Box 1766, Paoli PA
510(k) summary
Summary
Third party review
No

Clearances, product code JDS

Trailing 12 months

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

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