510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093361Substantially Equivalent

Synthes Air Pen Drive (Apd) System

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093361 is the FDA 510(k) clearance record for SYNTHES AIR PEN DRIVE (APD) SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code HBB (Motor, Drill, Pneumatic). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K093361.

Clearance record

Decision date
Received
(168 days to decision)
Product code
HBB Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
Device class
Class II
Review panel
Neurology
Applicant
Synthes (Usa) 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBB

Trailing 12 months
1 clearance under product code HBB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260