510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993099Substantially Equivalent

Bremer Halo System Titanium Skull Pin

Depuyacromed, Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993099 is the FDA 510(k) clearance record for BREMER HALO SYSTEM TITANIUM SKULL PIN, a class II device, cleared for Depuyacromed on under FDA product code JEC (Component, Traction, Invasive). FDA records list 48 510(k) clearances for Depuyacromed, from to . As of , FDA records show 15 recalls naming K993099.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Depuyacromed 325 Paramount Dr., Raynham MA
510(k) summary
Summary
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