510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040363Substantially Equivalent

Ceramic Tipped Skull Pin

The Jerome Group, Inc., Moorestown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040363 is the FDA 510(k) clearance record for CERAMIC TIPPED SKULL PIN, a class II device, cleared for The Jerome Group, Inc. on under FDA product code LYT (Fixation Accessory). FDA records list 2 510(k) clearances for The Jerome Group, Inc., from to . As of , FDA records show 4 recalls naming K040363.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LYT Fixation Accessory
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
The Jerome Group, Inc. 305 Harper Dr., Moorestown NJ
510(k) summary
Summary PDF
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