Home / 510(k) Clearances / K093361

510(k) K093361

SYNTHES AIR PEN DRIVE (APD) SYSTEM by Synthes (Usa) — Product Code HBB

K093361 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES AIR PEN DRIVE (APD) SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 2010. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2010
Date Received
October 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

Other clearances by Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

Other clearances for product code HBB

  • K253772 — Velocity Alpha MR High Speed Surgical Drill System (March 6, 2026)
  • K172907 — ELAN 4 Air Motor System (November 9, 2018)
  • K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpo (March 23, 2017)
  • K150801 — Stryker Maestro Air Motors (May 22, 2015)
  • K101168 — LEGEND POWER ADAPTER MODEL: 6475000 (August 24, 2010)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K061725 — STRYKER ARIA PNEUMATIC SYSTEM (October 26, 2006)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041754 — STRYKER MAESTRO SYSTEM (September 7, 2004)

FDA data resources